Clinical trial NCT02956447
Conditions: Hyperprolactinemia Hypogonadism
Keywords: Kisspeptin Hyperprolactinemia GnRH Hypogonadism
Sponsor: Massachusetts General Hospital
Start date: 2017-11-17; Completion date: 2023-07-29
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (IV) kisspeptin administration). Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.

Detailed description:

Arms: arm 1: Blood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 intravenously (IV). arm 2: Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.
Interventions: intervention 1: Kisspeptin 112-121 intervention 2: GnRH
Intervention descriptions: intervention 1: 0.313 ug/kg - 2 ug/kg IV or SC intervention 2: 0.075 ug/kg IV

Protocol documents:
Prot_SAP_000.pdf: 
VERSION 3.2           6/14/23             PROTOCOL # 2016P002281                                Page 1 of 8 
 
Kisspeptin Physiology in Patients with 
Hyperprolactinemia 
 
NCT02956447 
 
Study Protocol and Statistical Analysis Plan 
 
6/14/23 
 


VERSION 3.2           6/14/23             PROTOCOL # 2016P002281                                Page 2 of 8 
 
Protocol # 2016-P-002281 
 
Kisspeptin Physiology in Patients with Hyperprolactinemia 
 
BROAD GOALS 
The overall goals of this protocol are to stimulate gonadotropin secretion and folliculogenesis 
using exogenous kisspeptin administration. 
 
SPECIFIC AIMS 
Aim 1: To stimulate gonadotropin secretion using exogenous kisspeptin.  
Hypothesis: The inhibitory effect of hyperprolactinemia on GnRH secretion is mediated through 
kisspeptin. Therefore, kisspeptin administration to hyperprolactinemic women intolerant to 
conventional therapies will result in an increase in GnRH-induced gonadotropin release.  
 
Aim 2: To stimulate folliculogenesis using exogenous kisspeptin.  
Hypothesis: The suppression of folliculogenesis that occurs in hyperprolactinemia can be 
overcome by kisspeptin administration. Therefore, kisspeptin administration to 
hyperprolactinemic women intolerant to conventional therapies will result in mature follicle 
development. 
 
SUBJECT SELECTION 
This study will consist of two cohorts, one for each specific aim.   
 
Inclusion/Exclusion Criteria 
 
Inclusion: 
• 
Female, Ages 18-45, 
• 
Confirmed diagnosis by elevated levels of prolactin measured via blood test  
• 
Physical Examination: 
o normal blood pressure, (systolic BP < 140 mm Hg, diastolic < 90 mm Hg). 
• 
Laboratory Studies: 
o white blood cell, platelet counts, and TSH between 90% of the lower limit and 
110% of the upper limit of the reference range, 
o hemoglobin no less than 0.5 gm/dL below the lower limit of the reference range 
for normal women, 
o BUN, creatinine, AST, ALT not elevated, 
o negative serum hCG pregnancy test at the time of screening (additional urine 
pregnancy test will be conducted prior to drug administration). 
• 
Willing to complete a dopamine agonist washout period 6±2 weeks prior to each of the 
frequent blood sampling visits (Cohort 1) or 6±2 weeks prior to completing relevant 
screening labs until the end of the study (Cohort 2). The washout period will last at least 
4 weeks. 
• 
Not using oral contraceptives or willing to complete an oral contraceptive washout period 
8 weeks prior to each of the frequent blood sampling visits (Cohort 1) or 8 weeks prior to 
completing relevant screening labs until the end of the study (Cohort 2). 
 
Exclusion: 
• 
Patients with a macroprolactinoma confirmed on MRI Imaging 
• 
Current or recent use of a medication that, in the opinion of a study investigator, can 
modulate the reproductive axis 


VERSION 3.2           6/14/23             PROTOCOL # 2016P002281                                Page 3 of 8 
 
• 
History of a medication reaction requiring emergency medical care 
• 
A medical condition that, in the opinion of a study investigator, would likely interfere with 
participation in/completion of the protocol 
• 
Excessive alcohol consumption (>10 drinks/week) and/or use of illicit drugs 
• 
Pregnant or trying to become pregnant 
• 
Patients with a history of bilateral oophorectomy (ovaries were removed) 
• 
Breast feeding 
 
 
STUDY PROCEDURES 
 
General Outline of Protocol 
The goal of these studies is to assess the role of kisspeptin in GnRH and gonadotropin 
secretion as well as folliculogenesis in patients with hyperprolactinemia. GnRH cannot be 
measured in the peripheral circulation, and so LH will be measured as a surrogate marker of 
GnRH secretion. LH is secreted by the pituitary in direct response to GnRH, and there is a well-
established one-to-one concordance between GnRH and LH pulses. 1,2 
 
Medication Washout  
Cohort 2 subjects on dopamine agonists will be asked to complete a washout period 6±2 weeks 
prior to completing relevant screening labs and lasting until the end of the study. Cohort 2 
subjects on oral contraceptive pills will be asked to undergo a washout period of 8 weeks prior 
to completing relevant screening labs and lasting until the end of the study. Subjects will be 
asked to discuss the washout with their prescribing physician prior to beginning washout. Any 
subjects who experience intolerable side effects as a result of medication washout will end 
participation in the study and be instructed to follow recommendations by their prescribing 
physician regarding resuming any medications. 
 
Screening Visit 
The screening visit will include a complete history and physical examination and blood tests 
(listed below). The total volume of blood drawn during screening will not exceed 18mL.  
 
Screening laboratory tests 
• 
Progesterone, Estradiol, Prolactin 
• 
White blood cell count, platelet count, TSH, hemoglobin, BUN, creatinine, AST, ALT 
• 
Serum hCG pregnancy test 
 
Additional blood draws may be scheduled to repeat the progesterone and estradiol tests from 
the screening visit. This is to determine the phase of the menstrual cycle prior to subject’s study 
visits. The volume of blood drawn is approximately 5 mL. The total volume of blood drawn will 
not exceed PHRC guidelines.  
 
The screening history may be obtained by phone. Documentation of a physical examination 
performed by a non-study physician within the previous 12 months may be used in lieu of an in-
person physical examination; in this case, a physical examination will also be performed by a 
study physician at Visit 1. To obtain physical examination results performed off-site, subjects will 
be given an MGH “authorization for disclosure of medical information from another facility” form. 
If a physical examination is performed solely for the purposes of this study, study funds will pay 
for the cost of the physical examination. Remote screening laboratory studies will be performed 
at MGH on a blood sample shipped by the subject or at a local laboratory site (e.g. LabCorp, 


VERSION 3.2           6/14/23             PROTOCOL # 2016P002281                                Page 4 of 8 
 
Quest, etc.); study funds will pay for all phlebotomy and shipping costs. Laboratory studies 
already performed within the previous 6 months will be in lieu of repeating screening studies 
unless abnormal. 
 
Cohort 1 Protocol: Gonadotropin secretion (N=10) 
Subjects will complete four outpatient visits. Procedures for each visit are described below: 
 
Screening Visit: Described above 
 
If eligibility criteria are all met, a member of the study team will call the subject and schedule 
them for two visits at the Clinical Research Center.  
 
As mentioned above, we will ask subjects being treated with dopamine agonists to complete a 
washout period prior to the frequent blood sampling visit(s). The washout period will last at least 
4 weeks.  
 
Visit 1 
• 
Admission to the Clinical Research Center (CRC)  
• q10 minute blood sampling (3 mL q 10 min) x 12 hours without intervention to assess 
endogenous LH pulsatility. All samples will be assayed for LH. Progesterone (P4) will 
be measured on the first sample. FSH, prolactin, and estradiol (E2) will be assayed 
from pools of the frequent sampling studies.3,4   
 
Visit 2 (within 22 days of Visit 1) 
• 
Admission to the Clinical Research Center (CRC) 
• 
q10 minute sampling (3 mL q 10 min) x 12 hours 
• 
Administration of 10 boluses of kisspeptin 0.313 µg/kg IV every hour beginning at hour 1 
of the study. All samples will be assayed for LH. Progesterone (P4) will be measured on 
the first sample. FSH, prolactin, and estradiol (E2) will be assayed from pools of the 
frequent sampling studies.3,4   
• 
Administration of one bolus of GnRH 0.075 ug/kg IV at hour 11 of the study. 
 
Visit 3: Final follow-up study visit  
This visit will occur within a month after subjects have completed their Visit 2. The total blood 
drawn during this visit is 13mL. If any test result is abnormal, the subject will be followed until 
screening tests (CBC, BUN, creatinine, liver function studies) return to the ranges specified in 
eligibility criteria. If hemoglobin <10 g/dL then subjects will be provided with a one month supply 
of iron pills. 
 
Cohort 2 Protocol: Folliculogenesis (N=5) 
Subjects will complete 9 outpatient visits. Procedures for each visit are described below: 
 
Screening Visit: Described above 
If eligibility criteria are all met, a member of the study team will contact the subject to schedule 
Visit 1.  
 
Visit 1: Day 1 of kisspeptin administration 
• 
Participants will undergo a pelvic ultrasound to assess presence or absence of follicular 
growth. It is at investigator discretion to halt participation of any subject with evidence of 
follicular growth from the Visit 1 ultrasound.  


VERSION 3.2           6/14/23             PROTOCOL # 2016P002281                                Page 5 of 8 
 
• 
Participants will come to the Reproductive Endocrine Unit, or the CRC, where a study 
physician will initiate the administration of kisspeptin.  
o Option 1: Kisspeptin 0.313 – 13.19 μg/kg SC q60 – q240 minutes will be 
administered subcutaneously.  
o Option 2: Kisspeptin 0.313 μg/kg IV q 90 minutes will be administered using a 
closed IV system.  
• 
Up to 10 blood samples will be drawn during the visit. One or more 3mL samples will be 
collected just before the initial kisspeptin is delivered and additional 3mL samples will be 
collected after the bolus is delivered, over the course of the next 80 minutes (maximum 
total blood collection volume of 30mL) to define the LH response to the kisspeptin. All 
blood samples will be assayed for LH. P4 will be measured on the first sample, and 
prolactin will be measured on both the first and final samples. Pooled samples will be 
used for measurements of FSH and E2. Time of day of sample collection will be 
recorded. 
• 
Vital signs will be collected at least once during the visit. 
 
Visits 2-7: Daily blood sampling (days 2-7 of kisspeptin administration) 
• 
The GnRH-induced gonadotropin responses to a single bolus of kisspeptin 
(administered via pump(s)) will be monitored with up to 10 blood samples:  One or more 
3mL samples will be collected just before a kisspeptin bolus is delivered and additional 
3mL samples will be collected after the bolus is delivered, over the course of the next 80 
minutes, to define the LH response to the kisspeptin bolus. Maximum blood volume 
collected each day is 30mL . Sample collection will begin at the same time of the day ± 3 
hours from the time collection began at Visit 1. 
• 
All blood samples will be assayed for LH. P4 will be measured on the first sample, and 
prolactin will be measured on the first and final samples. Pooled samples will be used for 
measurements of FSH and E2. Time of day of sample collection will be recorded.  
• 
Pelvic ultrasounds will be performed at Visit 3 or Visit 4 to monitor follicular growth. This 
ultrasound is intended to ensure that the rate of follicular growth and number of follicles 
do not indicate hyperstimulation, which is considered extremely unlikely to occur, based 
on prior data of kisspeptin administration in this dose range. 
• 
Vital signs will be collected at least once during each daily visit. 
 
Visit 8: Final Visit (day 8 of kisspeptin administration) 
• 
At least 30 minutes after kisspeptin administration ends, participants will undergo final 
hormonal measurements: LH, FSH, E2, P4, prolactin; and safety laboratory studies: 
AST, ALT, BUN, Cr, hemoglobin, white blood cell, platelet counts, and TSH. The total 
blood drawn during this visit will not exceed 20mL. 
o The study team will contact participants if any safety value is outside the desired 
range (as stated in eligibility criteria) and arrange appropriate follow-up as 
needed. If hemoglobin <10 g/dL then subjects will be provided with a one-month 
supply of iron pills.   
• 
Pelvic ultrasound will be performed to assess follicular growth. 
 
Blood Draws:  
Cohort 1: The total volume of blood drawn during screening will not exceed 18ml. The 
progesterone and estradiol tests drawn at screening may be repeated; approximately 5mL will 
be drawn. The study subjects will undergo two 12 hour sampling studies on two separate days, 
approximately 220mL will be drawn for each study. The total volume of blood drawn for final 


VERSION 3.2           6/14/23             PROTOCOL # 2016P002281                                Page 6 of 8 
 
follow-up is approximately 13mL. The total volume of blood drawn over the course of the 
protocol is within PHRC guidelines and will not exceed 550 mL. 
 
Cohort 2: 
The total volume of blood drawn during screening is 13-18mL. Subjects will then undergo daily 
monitoring blood draws over 7 days. Total volume of blood drawn during Visits 1-7 will not 
exceed 30mL each day. The total volume of blood drawn during Visit 8 will not exceed 20mL. 
The total volume of blood drawn over the course of the protocol is within the PHRC guidelines 
and will not exceed 550 mL. 
 
If a study subject wants to participate in both Cohort 1 & Cohort 2, there will be a minimum of 8 
weeks between study participation in Cohort 1 and participation in Cohort 2, to conform with 
PHRC guidelines. 
 
Justification of doses: 
 
Kisspeptin IV: The dose of kisspeptin 112-121 0.313 μg/kg (0.24 nmol/kg) IV x1 is the same 
dose used in the PI’s studies in healthy men and women and is the dose predominantly used in 
the PI’s studies of men with IHH. This dose was chosen based on the first reported use of 
kisspeptin in humans, which showed that doses smaller than this dose (using a molar 
equivalent) elicited a smaller response (rise in LH), whereas larger doses did not elicit a larger 
response.5 In other words, a dose of 0.24 nmol/kg was the smallest dose to elicit a maximal 
response. A more recent report of dose-response studies with kisspeptin made similar findings.6 
The LH amplitudes of  kisspeptin-induced-GnRH- induced LH pulses are comparable to the LH 
amplitudes observed endogenously during the follicular and luteal phases of the female 
menstrual cycle  have LH amplitudes comparable to (follicular phase: kisspeptin induced LH 
amp 1.1 ± 1.0 vs. endogenous LH amp 1.2 ± 0.5 mIU/mL; mid-luteal phase: kisspeptin induced 
LH amp 4.0 ± 2.8 vs. endogenous LH amp 3.0 ± 1.5 mIU/mL)7 Moreover, in men, the range of 
LH amplitudes observed for kisspeptin-induced-GnRH-induced pulses overlaps the range of 
amplitudes that occurs endogenously(1.6 –10.9 and 0.5–7.8 mIU/ml, respectively).8 Thus, 
kisspeptin 0.24 nmol/kg (0.31 μg/kg) is a physiologic dose in healthy adults.  
 
Kisspeptin SC: The dose range of kisspeptin 112-121 is 0.313 μg/kg (0.24 nmol/kg) – 13.19 
μg/kg (10.1 nmol/kg). A range of doses is provided to account for a differential response of SC 
administration as compared to IV administration, as confirmed by the PI’s other work.   
 
GnRH: Long experience with GnRH has shown that a physiologic dose of GnRH is 25-75 
ng/kg.9 To ensure that a response to GnRH is seen, the dose of GnRH 75 ng/kg IV x1 is used in 
these protocols. The dose used to achieve pituitary priming is GnRH 25 ng/kg SC q2h x6d, 
which has been shown to successfully achieve priming.10  
Data suggests there is no interaction between kisspeptin administration and changes in 
prolactin levels in humans. Data recently published in Clinical Endocrinology show that prolactin 
levels are not significantly changed immediately following kisspeptin-54 injections (6.4 nmol/kg) 
in healthy women.11 Our group has observed similar short term results after administration of 
single boluses of kisspeptin-10 (0.313 µg/kg; 0.24 nmol/kg) in healthy men and men with IHH. 
Long-term follow up data collected by our group in healthy men, cycling women, and 
postmenopausal women, as well as men and women with IHH, also show that prolactin levels 
do not significantly change after administration of boluses or infusions of kisspeptin-10.  
 
Cohort 1 CRC Visits 


VERSION 3.2           6/14/23             PROTOCOL # 2016P002281                                Page 7 of 8 
 
Females will undergo a pregnancy test at screening and again at admission prior to receiving 
kisspeptin. Subjects will receive isovolumetric replacement with saline during blood sampling. 
Kisspeptin will be administered by a CRC RN.  Vital signs (HR, BP, RR, and T) will be 
measured every 1-4 hours throughout the frequent sampling portions of the protocol and every 
10 minutes for up to 30 minutes after kisspeptin administration.  
 
Termination criteria will include: 1) blood pressure > 180 mmHg systolic or >105 mmHg diastolic 
at any point during the protocol; 2) development or suspicion of an allergic or serious adverse 
reaction; 3) positive pregnancy test; 4) temperature ≥101.5°F at any point in the study. Any 
subject who develops high blood pressure or an allergic reaction will receive follow-up inpatient 
medical care until the issue is resolved, with subsequent outpatient and/or phone follow-up as 
needed. The CRC is fully equipped to handle medical emergencies, with trained staff, a bag-
valve mask in the room, a crash cart on the floor, and rapid access to a physician code team. 
 
Cohort 2 daily blood sampling visits 
Females will undergo a pregnancy test at screening and again prior to receiving kisspeptin. 
Kisspeptin will be administered via a pump(s). Vital signs (HR, BP, RR, and T) will be measured 
at least once during each daily blood sampling visit. 
 
Termination criteria will include: 1) blood pressure > 180 mmHg systolic or >105 mmHg diastolic 
at any point during the protocol; 2) development or suspicion of an allergic or serious adverse 
reaction; 3) positive pregnancy test; 4) temperature ≥101.5°F at any point in the study. Any 
subject who develops high blood pressure or an allergic reaction will receive follow-up inpatient 
medical care until the issue is resolved, with subsequent outpatient and/or phone follow-up as 
needed.  
 
BIOSTATISTICAL ANALYSIS 
 
Assays  
Given the long-term ongoing nature of this study, the assay methodologies employed to 
characterize the biochemical profile (both reproductive and metabolic) will be based on standard 
accepted methods as established by the Reproductive Endocrine Reference Laboratory. As 
such these methods may include immunoassays, measurement using standard laboratory 
platforms, radioimmunoassays, and mass spectroscopy. We anticipate that these methods will 
continue to evolve as the diagnostics field changes.  
  
Cohort 1 (Specific Aim 1)  
Population Size  
Each patient will serve as her own control. The primary outcome will be the number of LH 
pulses on the first biochemical assessment (no kisspeptin) compared to the second assessment 
(+kisspeptin).  Many studies in the literature have reported a decreased LH pulse frequency in 
hyperprolactinemia with one study (using q 10 minute sampling) documenting approximately 
2.25 pulses / 12 h in hyperprolactinemic individuals.12 During the second admission, by 
administering 10 boluses of kisspeptin, 10 LH pulses should be observed.  For the purposes of 
these calculations however, 8 pulses will be conservatively estimated because some of those 
pulses will coincide with/conceal endogenous pulses. For a difference of 8 and an SD of 6.8, 10 
subjects will need to be studied before and after kisspeptin to achieve 90% power at alpha = 
0.05.  
 
Data Analysis and Interpretation 


VERSION 3.2           6/14/23             PROTOCOL # 2016P002281                                Page 8 of 8 
 
LH pulses will be identified using a modified version of the Santen and Bardin method of pulse 
detection which has been validated in vivo.3,4  The primary outcome will be change in the 
frequency of LH pulses in response to kisspeptin administration.  The hypothesis will be 
accepted if the change in LH frequency on kisspeptin is higher during intermittent kisspeptin 
administration (second assessment) than in the absence of kisspeptin administration.  Mean LH 
level and LH pulse amplitude will also be calculated and used in secondary analyses.   
 
Cohort 2 (Specific Aim 2) 
Data analysis and interpretation 
The primary endpoint will be evidence of follicular growth from Visit 1 to Visit 8. We anticipate 
that to detect a mean difference of 7.8mm in maximum follicle size and a standard deviation of 
4.4, 5 subjects will need to be studied to achieve 80% power at alpha = 0.05.  
 
 
POTENTIAL BENEFITS 
Participants with hyperprolactinemia will not benefit directly from this study. The only benefit 
from participating in this study comes from the altruistic contribution to furthering our 
understanding of the biology of human reproduction. 
 
 
XI. REFERENCES 
1. 
Levine JE, Pau KY, Ramirez VD, Jackson GL. Simultaneous measurement of luteinizing 
hormone-releasing hormone and luteinizing hormone release in unanesthetized, ovariectomized 
sheep. Endocrinology 1982;111(5):1449-55. (In eng). DOI: 10.1210/endo-111-5-1449. 
2. 
Clarke IJ, Cummins JT. The temporal relationship between gonadotropin releasing hormone 
(GnRH) and luteinizing hormone (LH) secretion in ovariectomized ewes. Endocrinology 
1982;111(5):1737-9. (In eng). DOI: 10.1210/endo-111-5-1737. 
3. 
Hayes FJ, McNicholl DJ, Schoenfeld D, Marsh EE, Hall JE. Free alpha-subunit is superior to 
luteinizing hormone as a marker of gonadotropin-releasing hormone despite desensitization at 
fast pulse frequencies. J Clin Endocrinol Metab 1999;84(3):1028-36. (In eng) 
(http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_ui
ds=10084591). 
4. 
Santen RJ, Bardin CW. Episodic luteinizing hormone secretion in man. Pulse analysis, clinical 
interpretation, physiologic mechanisms. J Clin Invest 1973;52(10):2617-28. (In eng). DOI: 
10.1172/JCI107454. 
5. 
Dhillo WS, Chaudhri OB, Patterson M, et al. Kisspeptin-54 stimulates the hypothalamic-pituitary 
gonadal axis in human males. J Clin Endocrinol Metab 2005;90(12):6609-15. DOI: 
10.1210/jc.2005-1468. 
6. 
George JT, Veldhuis JD, Roseweir AK, et al. Kisspeptin-10 is a potent stimulator of LH and 
increases pulse frequency in men. J Clin Endocrinol Metab 2011;96(8):E1228-36. DOI: 
10.1210/jc.2011-0089. 
7. 
Chan YM, Butler JP, Sidhoum VF, Pinnell NE, Seminara SB. Kisspeptin administration to women: 
a window into endogenous kisspeptin secretion and GnRH responsiveness across the menstrual 
cycle. J Clin Endocrinol Metab 2012;97(8):E1458-67. (In eng). DOI: 10.1210/jc.2012-1282. 
8. 
Chan YM, Butler JP, Pinnell NE, et al. Kisspeptin resets the hypothalamic GnRH clock in men. J 
Clin Endocrinol Metab 2011;96(6):E908-15. (In eng). DOI: jc.2010-3046 [pii] 
10.1210/jc.2010-3046. 
9. 
Hoffman AR, Crowley WF, Jr. Induction of puberty in men by long-term pulsatile administration of 
low-dose gonadotropin-releasing hormone. N Engl J Med 1982;307(20):1237-41. DOI: 
10.1056/NEJM198211113072003. 
10. 
Pitteloud N, Thambundit A, Dwyer AA, et al. Role of seminiferous tubular development in 
determining the FSH versus LH responsiveness to GnRH in early sexual maturation. 
Neuroendocrinology 2009;90(3):260-8. DOI: 10.1159/000245383. 


VERSION 3.2           6/14/23             PROTOCOL # 2016P002281                                Page 9 of 8 
 
11. 
Jayasena CN, Comninos AN, Narayanaswamy S, et al. Acute and chronic effects of kisspeptin-54 
administration on GH, prolactin and TSH secretion in healthy women. Clin Endocrinol (Oxf) 
2014;81(6):891-8. DOI: 10.1111/cen.12512. 
12. 
Tay CC, Glasier AF, Illingworth PJ, Baird DT. Abnormal twenty-four hour pattern of pulsatile 
luteinizing hormone secretion and the response to naloxone in women with hyperprolactinaemic 
amenorrhoea. Clin Endocrinol (Oxf) 1993;39(5):599-606. 
(http://www.ncbi.nlm.nih.gov/pubmed/8252751). 
 

ICF_001.pdf: 
Kisspeptin Physiology in Patients with 
Hyperprolactinemia 
 
NCT02956447 
 
Intravenous Kisspeptin Arm Consent Form 
 
12/30/2020 
 


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 1 of 14
Subject Identification
Protocol Title: Kisspeptin Physiology in Patients with Hyperprolactinemia
Principal Investigator: Stephanie Seminara, MD
Site Principal Investigator:      
Description of Subject Population: Adult women age 18-45 with 
hyperprolactinemia
For Cohort group 1: Participants who will help us study    
gonadotropin secretion
About this consent form
Please read this form carefully.  It tells you important information about a research study.  A 
member of our research team will also talk to you about taking part in this research study.  
People who agree to take part in research studies are called “subjects.”  This term will be used 
throughout this consent form.
Partners HealthCare System is made up of Partners hospitals, health care providers, and 
researchers.  In the rest of this consent form, we refer to the Partners system simply as 
“Partners.”
If you have any questions about the research or about this form, please ask us.  Taking part in 
this research study is up to you.  If you decide to take part in this research study, you must sign 
this form to show that you want to take part.  We will give you a signed copy of this form to 
keep.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you.  At most, the 
Web site will include a summary of the results.  You can search this Web site at any time.
Why is this research study being done?
We are doing this research study to learn how a chemical called kisspeptin (pronounced “kiss-
pep-tin”) can be used in the treatment of hyperprolactinemia (higher than normal prolactin 
levels). We want to know how it controls the reproductive system in women with this condition, 
and what effect kisspeptin has on their reproductive hormone levels
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 2 of 14
Subject Identification
Reproductive hormones are chemicals the body makes naturally. A person needs a certain 
amount of reproductive hormones to be able to become pregnant. 
Kisspeptin is a chemical that is naturally made in the body. It is involved in reproduction, and is 
made in very high levels in women during pregnancy. 
Some studies in humans have shown that taking kisspeptin as a medication causes the body to 
produce hormones called gonadotropins (pronounced “go-nad-oh-trope-ins”). Gonadotropins 
travel through the body in the bloodstream. In women, they stimulate the ovaries to release an 
egg. As part of the study, you will also receive a hormone called GnRH (short for “gonadotropin-
releasing hormone”). GnRH stimulates the pituitary gland to produce gonadotropins and will be 
given to you to make sure your body is able to respond fully to kisspeptin.
Neither kisspeptin nor GnRH is approved by the U.S. Food and Drug Administration (FDA) as a 
drug to treat hyperprolactinemia but we have received permission from the FDA to use these 
investigational chemicals as part of this research study. 
We are asking you to take part in this study because you have been diagnosed with 
hyperprolactinemia and are between the ages of 18 and 45. 
About 60 women will take part in this research study at the Massachusetts General Hospital 
(MGH). 
Over 100 healthy volunteers taking part in research studies have received kisspeptin so far. No 
adverse effects related to kisspeptin have been observed. GnRH has been given to thousands of 
subjects and patients, and only one adverse effect has been reported. This was an allergic 
reaction, and it was not clear whether this reaction was related to GnRH.
The Massachusetts General Hospital is paying for this research to be done. 
How long will I take part in this research study?
You will complete one screening visit and three study visits. We may schedule additional blood 
draws to repeat some of the lab tests done at screening. The amount of time you spend on the 
study will depend on your availability to schedule the visits. However, we do not expect it will 
take more than 6 months.
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 3 of 14
Subject Identification
What will happen in this research study?
Screening Visit (about 1 hour)
For the screening visit you will come to the outpatient clinic of the MGH Reproductive 
Endocrine Unit for your initial evaluation. At this visit, we will: 

go over the study and ask you to sign this consent form,

ask you about your health and medical history, 

give you a physical exam

draw blood to measure your blood count, hormones, and to make sure you are generally 
healthy (may be conducted at the MGH Clinical Research Center).
Women who can become pregnant will also have a pregnancy test at this visit. 
You will be asked NOT to take any oral contraceptives, throughout the entire time that you are 
enrolled in the study. If you are currently taking a dopamine agonist such as cabergoline or 
bromocriptine, we will ask you to stop taking it for at least 6±2 weeks before any visit with 
frequent blood sampling.  
You may be asked to repeat some of the tests drawn at the screening visit to determine the phase 
of your menstrual cycle prior to your admissions to the Clinical Research Center. 
Visit 1: 1st admission to the MGH Clinical Research Center (The visit will take about 13 
hours to complete.)
If your screening results tell us that you qualify for the study, you will return to the hospital 
to be admited for Visit 1. This visit will take place up to 2 months from the screening visit 
depending on your availability. 
We will begin this study visit by giving you a urine pregnancy test to make sure you are not 
pregnant.  If you are not pregnant, we will place a thin, plastic tube called an intravenous line 
(IV) in your arm. The IV allows us to take many blood samples without having to use a 
needle each time.
Through the IV, we will draw a small amount of blood every 10 minutes for 12 hours to 
measure your hormones, including the gonadotropins (luteinizing hormone [LH] and follicle 
stimulating hormone [FSH]), estrogen, prolactin, and others. The IV will stay in your vein for 
the whole study visit. 
After the last blood draw we will remove the IV line, and you can go home. 
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 4 of 14
Subject Identification
We will call you within 48 hours after you leave the Clinical Research Center to check if there 
are any problems, and to see if you have any questions or concerns. 
Visit 2: 2nd admission to the MGH Clinical Research Center (The visit will take about 13 
hours to complete.)
This study visit will take place within 22 days from Visit 1. 
We will begin this study visit by giving you a urine pregnancy test to make sure you are not 
pregnant.  If you are not pregnant, we will place the IV in your arm. 
Through the IV, we will draw a small amount of blood every 10 minutes for 12 hours to 
measure your hormones, including the gonadotropins (luteinizing hormone [LH] and follicle 
stimulating hormone [FSH]), estrogen, prolactin, and others. The IV will stay in your vein for 
the whole study visit. 
We will give you 1 dose of kisspeptin every hour starting at hour 1 and ending at hour 10 of 
the study. This means you will receive a total of 10 kisspeptin doses in total. We will give 
you one dose of GnRH at hour 11 of the study. The doses will be given to you through the IV 
that is already in your arm. After the last blood draw we will remove the IV line, and you can 
go home. 
We will call you within 48 hours after you leave the Clinical Research Center to check if there 
are any problems, and to see if you have any questions or concerns. 
Visit 3: Follow-up visit (about 30 minutes)
Within a month after Visit 2, you will return for a short physical exam. During this visit we 
will also collect follow-up labs to make sure your lab values are in the study eligibility range. 
If any of your lab values are outside of this range, we will keep you in the study until your 
values have returned to normal. If your blood count is low, we will give you a 1 month 
supply of iron pills. 
You need to tell us if you have taken part in, or plan to take part in, any other research study 
while you are in this study.  Also, please let us know about any medical, diagnostic, or 
treatment activites, such as a new medicine or a trip to the doctor, during this study.  This is for 
your safety.
Stopping the Study Early 
You may decide to stop taking part in the study for any reason. Also, the study doctor may take 
you out of the study without your permission.  This may happen because:

The study doctor thinks it is best for you to stop taking the study drug

The study doctor thinks it is best for you to stop participating in the study
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 5 of 14
Subject Identification

You can’t make the required study visits

We stop doing the study for other reasons
If this happens, the study doctor will explain why you need to stop taking part in the study.  We 
will ask you to come in for a final study visit as described above.
Review of Medical Records from Hospital Admissions or Emergency Department Visits
Partners has an electronic system that lets your study doctors know if you are admitted to a 
Partners Hospital, or if you visit a Partners Hospital Emergency Department.  We want to make 
sure the study doctors know about any possible problems or side effects you experience while 
you are taking part in the study.
Storing Samples and Health Information at MGH for Future Use
We would like to store some of your samples and health information for future research related 
to reproductive disorders or kisspeptin physiology/safety.  We will label your samples and health 
information with a code instead of your name.  The key to the code connects your name to your 
samples and health information.  The study doctor will keep the key to the code in a [password 
protected computer/locked file].
Do you agree to let us store your samples and health information for future research related to 
reproductive disorders or kisspeptin physiology/safety?
 Yes
 No Initials___________
If later you change your mind and want your samples destroyed, contact the study doctor.
Use of your Information from this Research Study 
In the past you may have participated in a study in the Reproductive Endocrine Unit including 
providing a blood sample, spending a night in the hospital, or receiving medication/treatment. 
All study information, past and future including genetic studies will be used collectively for 
ongoing research and to improve our understanding of reproductive disorders. This includes 
information from other Reproductive Endocrine Unit studies you have completed or will take 
part in. 
As we learn more about your condition, we may want to contact you about additional studies. 
Study Information Included in Your Electronic Medical Record
A notation that you are taking part in this research study may be made in your electronic medical 
record.  Information from the research that relates to your general medical care may be included 
in the record (for example, list of allergies, results of standard blood tests done at the hospital 
labs).
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 6 of 14
Subject Identification
Please ask your study doctor if you have any questions about what information will be included 
in your electronic medical record.
What are the risks and possible discomforts from being in this research 
study?
The risks involved with this study include:
Risk of Allergic Reaction: 
With any drug, an allergic reaction can occur. Allergic reactions can be mild or more serious 
and can even result in death. Common symptoms of an allergic reaction are rash, itching, 
skin problems, swelling of the face and throat, or trouble breathing. If you think you are 
having an allergic reaction, call the study doctor right away.  If you are having trouble 
breathing, call 911 immediately.
Risks of Kisspeptin: 
Kisspeptin is naturally made in the human body. This drug has been given to healthy men and 
women, patients attempting fertility and patients with reproductive disorders. We also studied the 
effects of high doses of kisspeptin on rats and dogs and no side effects were seen. There have 
been no serious side effects seen in either animal or human studies. However, there may be risks 
of kisspeptin that are currently unknown, including side effects that may happen when taking 
kisspeptin with other drugs.
For your safety during this study, call your study doctor BEFORE you take any:

new medications prescribed by your own doctor

other medications sold over-the-counter without a prescription

dietary or herbal supplements
Risks to an Embryo or Fetus, or to a Breastfeeding Infant
We do not believe that kisspeptin has any risk to an embryo or fetus (unborn baby in the 
womb). This is largely based on studies showing very high levels during pregnancy. There 
may be harmful risks that are unknown. Therefore, women cannot take part in the study if 
they are:

pregnant

breastfeeding

trying to become pregnant
If you have had any well-documented method of surgical sterilization, you will not need to have 
a pregnancy test.  Some methods of surgical sterilization include having had a hysterectomy 
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 7 of 14
Subject Identification
(removal of the uterus), a tubal ligation (having your tubes tied), and transvaginal occlusion 
(plugging the opening of the tubes with a coil).  If none of these apply to you, you must have a 
negative pregnancy test before starting the study drug.
If you are sexually active and able to become pregnant, you must agree to use two of the birth 
control methods listed below.  You must use two forms of birth control for the entire study and 
for one month after your last dose of study drug. 
Acceptable birth control methods for use in this study are:

barrier methods (such as a condom or diaphragm) used with a spermicide (a 
foam, cream, or gel that kills sperm)

intrauterine device (IUD)

abstinence (no sex)
The study investigator will discuss your choices for birth control during the study.
If you think you might be pregnant during the study, you must tell the study doctor.  If you 
become pregnant, you must stop taking the study drug and stop taking part in the study.  The 
study doctor may ask for your permission to collect information about the outcome of your 
pregnancy and the condition of your newborn. 
Risks of Gonadotropin-Releasing Hormone (GnRH)
GnRH has been given to patients for more than 30 years and it is approved by the FDA for 
ovulation induction in women. There have been no serious side effects that were felt to be related 
to GnRH in human studies aside from a single report of a possible allergic reaction.
Risks of Blood Draws and IV Lines:
The total amount of blood drawn in this study is less than 2 cups. By comparison, the Red 
Cross allows a healthy adult to donate 1 unit (about 2 cups) of blood every 8 weeks. A 
healthy person will normally replace this amount of blood in that time period.
You should not donate blood or have large amounts of blood drawn for 8 weeks after the 
study.
You may have a bruise (a black and blue mark) or pain where we take the blood samples and/or 
put in an IV line.  There is also a small risk of infection, lightheadedness, and/or fainting, as well 
as a slight chance that an IV line may stop working. If an IV line stops working, we will put in a 
new one.  Also, it is possible that you could develop anemia from blood-drawing, should this 
happen we will provide iron supplements. You may feel fatigued after blood-drawing. 
Risks of Iron Supplements
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 8 of 14
Subject Identification
Iron supplements may occasionally cause mild gastrointestinal (stomach and digestion) 
problems, including constipation and darkening of the stool.
Dopamine Agonist Treatment Washout
If you take a dopamine agonist such as cabergoline or bromocriptine and you stop taking it, you 
may notice that your original symptoms may come back. These symptoms may include a lack of 
menstrual period, sexual dysfunction, and/or a milky liquid coming out of your breast(s) 
(galactorrhea). However, because our washout period is relatively short, we do not expect you to 
have these symptoms for very long and expect any short-term symptoms to quickly go away 
when you begin taking cabergoline or bromocriptine again.
Unknown Risks
There may be other risks of kisspeptin and GnRH that are currently unknown.
What are the possible benefits from being in this research study?
You will not directly benefit from taking part in this research study.  
What other treatments or procedures are available for my condition?
You do not have to take part in this research study to be treated for hyperprolactinemia. Other 
treatments that are available to treat hyperprolactinemia include dopamine agonist therapy with 
bromocriptine or cabergoline. 
Can I still get medical care within Partners if I don’t take part in this 
research study, or if I stop taking part? 
Yes.  Your decision won’t change the medical care you get within Partners now or in the future.  
There will be no penalty, and you won’t lose any benefits you receive now or have a right to 
receive.
Taking part in this research study is up to you.  You can decide not to take part.  If you decide to 
take part now, you can change your mind and drop out later.  We will tell you if we learn new 
information that could make you change your mind about taking part in this research study.
What should I do if I want to stop taking part in the study?
If you take part in this research study, and want to drop out, you should tell us.  We will make 
sure that you stop the study safely.  We will also talk to you about follow-up care, if needed.
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 9 of 14
Subject Identification
Also, it is possible that we will have to ask you to drop out of the study before you finish it.  If 
this happens, we will tell you why.  We will also help arrange other care for you, if needed.
Will I be paid to take part in this research study?
Group 1 will receive up to $1000 for completing the study.
Screening visit: $20
Visit 1 (CRC Visit 1): $480 ($260 at time of visit; $220 at end of study).
Visit 2 (CRC Visit 2): $480 ($260 at time of visit; $220 at end of study).
Visit 3 (Follow-up Visit): $20
We will give you meals during the Clinical Research Center admissions. We will give you a 
parking coupon to pay for your parking in the hospital garage during study visits. If you are 
traveling from a distance, we may also defray transportation and hotel costs. 
If there is an extra follow-up visit because you have a problem during the study, we will not pay 
you for the extra follow-up visit.
What will I have to pay for if I take part in this research study?
Study funds will pay for study-related items and services.  We may bill your health insurer for, 
among other things, routine items and services you would have received even if you did not take 
part in the research.  You will be responsible for payment of any deductibles and co-payments 
required by your insurer for this routine care or other billed care.  If you have any questions 
about costs to you that may result from taking part in the research, please speak with the study 
doctors and study staff.  If necessary, we will arrange for you to speak with someone in Patient 
Financial Services about these costs.
What happens if I am injured as a result of taking part in this research 
study?
We will offer you the care needed to treat any injury that directly results from taking part in this 
research study.  We reserve the right to bill your insurance company or other third parties, if 
appropriate, for the care you get for the injury.  We will try to have these costs paid for, but you 
may be responsible for some of them.  For example, if the care is billed to your insurer, you will 
be responsible for payment of any deductibles and co-payments required by your insurer.
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 10 of 14
Subject Identification
Injuries sometimes happen in research even when no one is at fault.  There are no plans to pay 
you or give you other compensation for an injury, should one occur.  However, you are not 
giving up any of your legal rights by signing this form.
If you think you have been injured or have experienced a medical problem as a result of taking 
part in this research study, tell the person in charge of this study as soon as possible.  The 
researcher's name and phone number are listed in the next section of this consent form.
If I have questions or concerns about this research study, whom can I 
call?
You can call us with your questions or concerns.  Our telephone numbers are listed below.  Ask 
questions as often as you want.  
Stephanie Seminara, M.D. is the person in charge of this research study.  You can call her at 
 (Monday-Friday 9-5) or page her (#
) 24 hours a day, 7 days a week with 
questions about this research study. You can also call Margaret Lippincott, M.D. at 
 (Monday-Friday 9-5) or page her (6
 pager # 
) 24 hours a day, 7 days a 
week with questions about this research study. 
If you have questions about the scheduling of appointments or study visits, call 
 or 
email mghkisspeptinresearch@partners.org.
If you want to speak with someone not directly involved in this research study, please contact 
the Partners Human Research Committee office.  You can call them at 857-282-1900.
You can talk to them about:

Your rights as a research subject

Your concerns about the research

A complaint about the research
Also, if you feel pressured to take part in this research study, or to continue with it, they want to 
know and can help.
If I take part in this research study, how will you protect my privacy?
During this research, identifiable information about your health will be collected.  In the rest of 
this section, we refer to this information simply as “health information.”  In general, under 
federal law, health information is private.  However, there are exceptions to this rule, and you 
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 11 of 14
Subject Identification
should know who may be able to see, use, and share your health information for research and 
why they may need to do so.   
In this study, we may collect health information about you from:

Past, present, and future medical records

Research procedures, including research office visits, tests, interviews, and 
questionnaires
Who may see, use, and share your identifiable health information and why they may 
need to do so:

Partners research staff involved in this study

The sponsor(s) of this study, and the people or groups it hires to help perform this 
research

Other researchers and medical centers that are part of this study and their ethics boards

A group that oversees the data (study information) and safety of this research

Non-research staff within Partners who need this information to do their jobs (such as for 
treatment, payment (billing), or health care operations)

The Partners ethics board that oversees the research and the Partners research quality 
improvement programs.

People from organizations that provide independent accreditation and oversight of 
hospitals and research

People or groups that we hire to do work for us, such as data storage companies, insurers, 
and lawyers

Federal and state agencies (such as the Food and Drug Administration, the Department of 
Health and Human Services, the National Institutes of Health, and other US or foreign 
government bodies that oversee or review research) 

Public health and safety authorities (for example, if we learn information that could mean 
harm to you or others, we may need to report this, as required by law)

Other:  researchers and medical centers that may do similar research in 
the future.
Some people or groups who get your health information might not have to follow the same 
privacy rules that we follow and might use or share your health information without your 
permission in ways that are not described in this form.  For example, we understand that the 
sponsor of this study may use your health information to perform additional research on various 
products or conditions, to obtain regulatory approval of its products, to propose new products, 
and to oversee and improve its products’ performance.  We share your health information only 
when we must, and we ask anyone who receives it from us to take measures to protect your 
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 12 of 14
Subject Identification
privacy.  The sponsor has agreed that it will not contact you without your permission and will not 
use or share your information for any mailing or marketing list.  However, once your information 
is shared outside Partners, we cannot control all the ways that others use or share it and cannot 
promise that it will remain private.
Because research is an ongoing process, we cannot give you an exact date when we will either 
destroy or stop using or sharing your health information.
The results of this research study may be published in a medical book or journal, or used to teach 
others.  However, your name or other identifying information will not be used for these purposes 
without your specific permission.
Your Privacy Rights
You have the right not to sign this form that allows us to use and share your health information 
for research; however, if you don’t sign it, you can’t take part in this research study.   
You have the right to withdraw your permission for us to use or share your health information 
for this research study.  If you want to withdraw your permission, you must notify the person in 
charge of this research study in writing.  Once permission is withdrawn, you cannot continue to 
take part in the study.
If you withdraw your permission, we will not be able to take back information that has already 
been used or shared with others.
You have the right to see and get a copy of your health information that is used or shared for 
treatment or for payment.  To ask for this information, please contact the person in charge of this 
research study.  You may only get such information after the research is finished. 
Informed Consent and Authorization
Statement of Person Giving Informed Consent and Authorization

I have read this consent form.

This research study has been explained to me, including risks and possible benefits (if 
any), other possible treatments or procedures, and other important things about the study.

I have had the opportunity to ask questions.

I understand the information given to me.
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  December 2008
Page 13 of 14
Subject Identification
Signature of Subject:
I give my consent to take part in this research study and agree to allow my health information to 
be used and shared as described above.
Subject
Date
Time (optional)
Signature of Study Doctor or Person Obtaining Consent:
Statement of Study Doctor or Person Obtaining Consent

I have explained the research to the study subject.

I have answered all questions about this research study to the best of my ability.
Study Doctor or Person Obtaining Consent
Date
Time (optional)
Consent of Non-English Speaking Subjects Using the “Short Form” in the 
Subject’s Spoken Language
Statement of Hospital Medical Interpreter
As someone who understands both English and the language spoken by the subject, I interpreted, 
in the subject's language, the researcher's presentation of the English consent form.  The subject 
was given the opportunity to ask questions.
Hospital Medical Interpreter
Date
Time (optional)
OR
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 14 of 14
Subject Identification
Statement of Other Individual (Non-Interpreter)
As someone who understands both English and the language spoken by the subject, I represent 
that the English version of the consent form was presented orally to the subject in the subject’s 
own language, and that the subject was given the opportunity to ask questions.
Name
Date
Time (optional)
Permission for Future Contact
We may want to contact you about additional studies in the future.  Do you give permission 
for us to contact you about future studies? 
⁭ YES, I give permission to be contacted about future studies.
⁭ NO, I do NOT wish to be contacted about future studies. 
Subject
Date
Consent Form Version:  1/29/2020
Consent Form Title: Cohort 1_Consent_Form_HPRL_2020_1_29_Clean
IRB Protocol No: 2016P002281
Sponsor Protocol No: Detailed Protocol_HPRL_ 2020_12_23 / 1.9
Consent Form Valid Date: 12/30/2020
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 1/8/2022
IRB Amendment Approval Date: N/A


Kisspeptin Physiology in Patients with 
Hyperprolactinemia 
 
NCT02956447 
 
Subcutaneous Kisspeptin Arm Consent Form 
 
06/21/2023 
 


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 1 of 14
Subject Identification
Protocol Title: Kisspeptin Physiology in Patients with Hyperprolactinemia
Principal Investigator: Stephanie Seminara, MD
Site Principal Investigator:      
Description of Subject Population: Adult women age 18-45 with 
hyperprolactinemia
For Cohort group 2: Participants who will help us study 
Folliculogenesis-the process your body goes through to develop an 
egg in your ovary
About this consent form
Please read this form carefully.  It tells you important information about a research study.  A 
member of our research team will also talk to you about taking part in this research study.  
People who agree to take part in research studies are called “subjects.”  This term will be used 
throughout this consent form.
Partners HealthCare System is made up of Partners hospitals, health care providers, and 
researchers.  In the rest of this consent form, we refer to the Partners system simply as 
“Partners.”
If you have any questions about the research or about this form, please ask us.  Taking part in 
this research study is up to you.  If you decide to take part in this research study, you must sign 
this form to show that you want to take part.  We will give you a signed copy of this form to 
keep.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you.  At most, the 
Web site will include a summary of the results.  You can search this Web site at any time.
Why is this research study being done?
We are doing this research study to learn how a chemical called kisspeptin (pronounced “kiss-
pep-tin”) can be used in the treatment of hyperprolactinemia (higher than normal prolactin 
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 2 of 14
Subject Identification
levels). We want to know how it controls the reproductive system in women with this condition 
and if this drug can help these women with high prolactin levels to ovulate.
Reproductive hormones are chemicals the body makes naturally. A person needs a certain 
amount of reproductive hormones to be able to become pregnant. 
Kisspeptin is a chemical that is naturally made in the body. It is involved in reproduction and is 
made in very high levels in women during pregnancy. 
Some studies in humans have shown that taking kisspeptin as a medication causes the body to 
produce hormones called gonadotropins (pronounced “go-nad-oh-trope-ins”). Gonadotropins 
travel through the body in the bloodstream. In women, they stimulate the ovaries to release an 
egg. 
Kisspeptin is not approved by the U.S. Food and Drug Administration (FDA) as a drug to treat 
hyperprolactinemia but we have received permission from the FDA to use this investigational 
chemical as part of this research study. 
We are asking you to take part in this study because you have been diagnosed with 
hyperprolactinemia and are between the ages of 18 and 45. 
About 41 women will take part in this research study at the Massachusetts General Hospital 
(MGH). 
Over 100 healthy volunteers taking part in research studies have received kisspeptin so far. No 
adverse effects related to kisspeptin have been observed.
The Massachusetts General Hospital and the FDA are paying for this research to be done. 
How long will I take part in this research study?
You will complete one screening visit and 8 study visits. The amount of time you spend on the 
study will depend on your availability to schedule the visits. However, we do not expect it will 
take more than 6 months.
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 3 of 14
Subject Identification
What will happen in this research study?
All visits may take place at either the outpatient clinic of the MGH Reproductive Endocrine Unit 
or at the MGH Clinical Research Center.
If you sign this consent form and are currently taking a dopamine agonist, such as cabergoline or 
bromocriptine, we will ask you to stop taking it, starting 4 to 8 weeks prior to completing 
screening blood work and continuing until the end of the study. Additionally, if you are taking an 
oral contraceptive, we will ask you to stop taking it for the same time period. This “washout 
period” allows your regular medications to leave your body before we measure your hormone 
levels and general indicators of your health. Please discuss the washout period with your 
prescribing physician prior to beginning the washout. Without your regular medications, your 
medical condition or symptoms may get worse. If this happens, please call the study doctor at the 
number provided in this consent form. Your chances of becoming pregnant increase when you 
stop taking an oral contraceptive. As described later in this document, you will need to use 
alternate forms of birth control to participate in the study.
You need to tell us if you have taken part in, or plan to take part in, any other research study 
while you are in this study. Also, please let us know about any medical, diagnostic, or 
treatment activites, such as a new medicine or a trip to the doctor, during this study. This is for 
your safety.
Screening Visit (about 1 hour)
At this visit, we will: 
•
ask you about your health and medical history, 
•
give you a physical exam,
•
draw blood to measure your blood count, hormones, and to make sure you are generally 
healthy 
Women who can become pregnant will also have a pregnancy test at this visit. 
Visit 1: Kisspeptin pump(s) placement- day 1 of kisspeptin administration (about 2.5 
hours)
At this visit, you will undergo a pelvic ultrasound. If the results of the Visit 1 ultrasound indicate 
that you have the potential to ovulate an egg in your current menstrual cycle, we might stop your 
participation in the study.
We will place a pump(s) device that will give you kisspeptin subcutaneously (SC, under the 
skin), or intravenously (IV, inside the vein). The pump is about the size of a deck of cards, and it 
can be carried in your pocket or clipped to your belt. A thin, flexible tube will carry the 
kisspeptin from the pump(s) to your body. The pump(s) should not interfere with your daily 
activities. You will be asked to wear this device for 8 days. 
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 4 of 14
Subject Identification
You might be asked to wear only one pump, or you might be asked to wear two of the small 
pump devices at the same time. If you are asked to wear two pumps, you would have two 
insertion sites, one in each of two locations on your abdomen.
During this visit, we will collect up to a maximum of 10 blood samples (about two tablespoons 
in total). The first blood samples will be collected just before the pump(s) gives you the first dose 
of kisspeptin. We will then collect additional samples after the dose has been delivered. These 
blood samples will be used to measure LH (Luteinizing Hormone), FSH (Follicle Stimulating 
Hormone), estradiol (estrogen), prolactin and other hormones. 
Visits 2-7: Daily blood sampling- days 2-7 of kisspeptin administration (about 2.5 hours)
We will ask you to come in every day at the same time of day for 6 days, in order to collect up to 
10 blood samples over a period of up to 90 minutes. The blood samples will be used to measure 
LH, FSH, estradiol, prolactin and other hormones.
During Visit 3 or 4, you will undergo a pelvic ultrasound to continue monitoring your ovaries.
Visit 8: Final Visit – day 8 of kisspeptin administration (about 1.5 hours)
During Visit 8, you will undergo a pelvic ultrasound and the pump(s) will be removed. We will 
also repeat safety and hormone labs. If your blood count is low, we will give you a 1-month 
supply of iron pills.
Stopping the Study Early 
You may decide to stop taking part in the study for any reason. Also, the study doctor may take 
you out of the study without your permission.  This may happen because:
•
The study doctor thinks it is best for you to stop taking the study drug
•
The study doctor thinks it is best for you to stop participating in the study
•
You can’t make the required study visits
•
We stop doing the study for other reasons
If this happens, the study doctor will explain why you need to stop taking part in the study.  We 
will ask you to come in for a final study visit. During this visit you may undergo a pelvic 
ultrasound and we will collect a blood sample for safety and hormone labs. 
Review of Medical Records from Hospital Admissions or Emergency Department Visits
Partners has an electronic system that lets your study doctors know if you are admitted to a 
Partners Hospital, or if you visit a Partners Hospital Emergency Department.  We want to make 
sure the study doctors know about any possible problems or side effects you experience while 
you are taking part in the study.
Storing Samples and Health Information at MGH for Future Use
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 5 of 14
Subject Identification
We would like to store some of your samples and health information for future research related 
to reproductive disorders or kisspeptin physiology/safety.  We will label your samples and health 
information with a code instead of your name.  The key to the code connects your name to your 
samples and health information.  The study doctor will keep the key to the code in a [password 
protected computer/locked file].
Do you agree to let us store your samples and health information for future research related to 
reproductive disorders or kisspeptin physiology/safety?
 Yes 
 No
Initials___________
If later you change your mind and want your samples destroyed, contact the study doctor.
Use of your Information from this Research Study 
In the past you may have participated in a study in the Reproductive Endocrine Unit including 
providing a blood sample, spending a night in the hospital, or receiving medication/treatment. 
All study information, past and future including genetic studies will be used collectively for 
ongoing research and to improve our understanding of reproductive disorders. This includes 
information from other Reproductive Endocrine Unit studies you have completed or will take 
part in. 
As we learn more about your condition, we may want to contact you about additional studies. 
Study Information Included in Your Electronic Medical Record
A notation that you are taking part in this research study may be made in your electronic medical 
record.  Information from the research that relates to your general medical care may be included 
in the record (for example, list of allergies, results of standard blood tests done at the hospital 
labs).
Please ask your study doctor if you have any questions about what information will be included 
in your electronic medical record.
What are the risks and possible discomforts from being in this research 
study?
The risks involved with this study include:
Risk of Allergic Reaction: 
With any drug, an allergic reaction can occur. Allergic reactions can be mild or more serious 
and can even result in death. Common symptoms of an allergic reaction are rash, itching, 
skin problems, swelling of the face and throat, or trouble breathing. If you think you are 
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 6 of 14
Subject Identification
having an allergic reaction, call the study doctor right away.  If you are having trouble 
breathing, call 911 immediately.
Risks of Kisspeptin: 
Kisspeptin is naturally made in the human body. This drug has been given to healthy men and 
women, patients attempting fertility and patients with reproductive disorders. We also studied the 
effects of high doses of kisspeptin on rats and dogs and no side effects were seen. There have 
been no serious side effects seen in either animal or human studies. However, there may be risks 
of kisspeptin that are currently unknown, including side effects that may happen when taking 
kisspeptin with other drugs.
For your safety during this study, call your study doctor BEFORE you take any:
•
new medications prescribed by your own doctor
•
other medications sold over-the-counter without a prescription
•
dietary or herbal supplements
Risks to an Embryo or Fetus, or to a Breastfeeding Infant
We do not believe that kisspeptin has any risk to an embryo or fetus (unborn baby in the 
womb). This is largely based on studies showing very high levels during pregnancy. There 
may be harmful risks that are unknown. Therefore, women cannot take part in the study if 
they are:
•
pregnant
•
breastfeeding
•
trying to become pregnant
If you have had any well-documented method of surgical sterilization, you will not need to have 
a pregnancy test.  Some methods of surgical sterilization include having had a hysterectomy 
(removal of the uterus), a tubal ligation (having your tubes tied), and transvaginal occlusion 
(plugging the opening of the tubes with a coil).  If none of these apply to you, you must have a 
negative pregnancy test before starting the study drug.
If you are sexually active and able to become pregnant, you must agree to use two of the birth 
control methods listed below.  You must use two forms of birth control for the entire study and 
for one month after your last dose of study drug. 
Acceptable birth control methods for use in this study are:
•
barrier methods (such as a condom or diaphragm) used with a spermicide (a 
foam, cream, or gel that kills sperm)
•
intrauterine device (IUD)
•
abstinence (no sex)
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 7 of 14
Subject Identification
The study investigator will discuss your choices for birth control during the study.
If you think you might be pregnant during the study, you must tell the study doctor.  If you 
become pregnant, you must stop taking the study drug and stop taking part in the study.  The 
study doctor may ask for your permission to collect information about the outcome of your 
pregnancy and the condition of your newborn. 
Ultrasound
Pelvic ultrasounds will be performed. There are no known radiation risks associated with 
standard ultrasound procedures. The ultrasound uses sound waves to create a picture of the 
internal parts of your body and can be done either transvaginally or transabdominally.  The exam 
takes about 30 minutes.  The transvaginal route gives the best picture of the uterus and ovaries 
and is the preferred way to do the ultrasound. The transvaginal ultrasound involves the 
temporary insertion of a probe into the vagina to image the ovaries and uterus and may involve 
some mild discomfort (less than that associated with a Pap smear).  If you do not want the 
transvaginal ultrasound, or if you have not been sexually active previously, the ultrasound will be 
performed through the abdominal wall, when the bladder is full.  The probe is passed back and 
forth over the abdomen (similar to ultrasounds done for pregnant women).  The transabdominal 
ultrasound may involve some discomfort from the pressure placed on the abdomen, as your 
bladder must be full to adequately visualize the pelvic organs via this method. 
Risks of Blood Draws and IV and SC Administration of study drug:
The total amount of blood drawn in this study is up to about 1 cup. The Red Cross allows a 
healthy adult to donate 1 unit (about 2 cups) of blood every 8 weeks. A healthy person will 
normally replace this amount of blood in that time period.
You should not donate blood or have large amounts of blood drawn for 8 weeks after the 
study.
You may have a bruise (a black and blue mark) or pain where we take the blood samples and/or 
put in an IV line.  There is also a small risk of infection, lightheadedness, and/or fainting, as well 
as a slight chance that an IV line may stop working. If an IV line stops working, we will put in a 
new one. Also, it is possible that you could develop anemia from blood-drawing. Should this 
happen, we will provide you with iron supplements. You may feel fatigued after blood-drawing. 
There is a possibility of a reaction at the site(s) of SC study drug administration, including: pain, 
tenderness, warmth, itching, swelling, irritation, redness, or bruising.
Risks of Iron Supplements
Iron supplements may occasionally cause mild gastrointestinal (stomach and digestion) 
problems, including constipation and darkening of the stool.
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 8 of 14
Subject Identification
Dopamine Agonist and/or Oral Contraceptive Treatment Washout
If you take a dopamine agonist such as cabergoline or bromocriptine and you stop taking it, you 
might notice that your original symptoms come back, to some degree. These symptoms may 
include a lack of menstrual period, sexual dysfunction, and/or a milky liquid coming out of your 
breast(s) (galactorrhea). However, because the washout period needed to participate in the study 
is relatively short, we do not expect you to have these symptoms for very long and expect any 
short-term symptoms to quickly go away when you begin taking cabergoline or bromocriptine 
again. If you stop taking an oral contraceptive, you might experience the return of some 
symptoms that the medication lessened, and the likelihood of becoming pregnant increases, 
unless you are abstinent or use another highly effective form of contraception. When you start 
taking your oral contraceptive again, if you decide to, these changes should go away quickly.
Unknown Risks
There may be other risks of kisspeptin that are currently unknown.
What are the possible benefits from being in this research study?
You will not directly benefit from taking part in this research study.  
What other treatments or procedures are available for my condition?
You do not have to take part in this research study to be treated for hyperprolactinemia. Other 
treatments that are available to treat hyperprolactinemia include dopamine agonist therapy with 
bromocriptine or cabergoline. 
Can I still get medical care within Partners if I don’t take part in this 
research study, or if I stop taking part? 
Yes.  Your decision won’t change the medical care you get within Partners now or in the future.  
There will be no penalty, and you won’t lose any benefits you receive now or have a right to 
receive.
Taking part in this research study is up to you.  You can decide not to take part.  If you decide to 
take part now, you can change your mind and drop out later.  We will tell you if we learn new 
information that could make you change your mind about taking part in this research study.
What should I do if I want to stop taking part in the study?
If you take part in this research study, and want to drop out, you should tell us.  We will make 
sure that you stop the study safely.  We will also talk to you about follow-up care, if needed.
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 9 of 14
Subject Identification
Also, it is possible that we will have to ask you to drop out of the study before you finish it.  If 
this happens, we will tell you why.  We will also help arrange other care for you, if needed.
Will I be paid to take part in this research study?
You will receive up to $1190 for completing the study.
Screening visit: $40
Visits 1-7: $150/visit
Visit 8: $100
Follow up visit (if participation stopped early): $40
Depending on the timing of your visit, we may give you meals during your time in the Clinical 
Research Center. We will give you a parking coupon to pay for your parking in the hospital 
garage during study visits. If you are traveling from a distance, we may also defray 
transportation and hotel costs. 
What will I have to pay for if I take part in this research study?
Study funds will pay for study-related items and services.  We may bill your health insurer for, 
among other things, routine items and services you would have received even if you did not take 
part in the research.  You will be responsible for payment of any deductibles and co-payments 
required by your insurer for this routine care or other billed care.  If you have any questions 
about costs to you that may result from taking part in the research, please speak with the study 
doctors and study staff.  If necessary, we will arrange for you to speak with someone in Patient 
Financial Services about these costs.
What happens if I am injured as a result of taking part in this research 
study?
We will offer you the care needed to treat any injury that directly results from taking part in this 
research study.  We reserve the right to bill your insurance company or other third parties, if 
appropriate, for the care you get for the injury.  We will try to have these costs paid for, but you 
may be responsible for some of them.  For example, if the care is billed to your insurer, you will 
be responsible for payment of any deductibles and co-payments required by your insurer.
Injuries sometimes happen in research even when no one is at fault.  There are no plans to pay 
you or give you other compensation for an injury, should one occur.  However, you are not 
giving up any of your legal rights by signing this form.
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 10 of 14
Subject Identification
If you think you have been injured or have experienced a medical problem as a result of taking 
part in this research study, tell the person in charge of this study as soon as possible.  The 
researcher's name and phone number are listed in the next section of this consent form.
If I have questions or concerns about this research study, whom can I 
call?
You can call us with your questions or concerns.  Our telephone numbers are listed below.  Ask 
questions as often as you want.  
Stephanie Seminara, M.D. is the person in charge of this research study.  You can call her at 
 (Monday-Friday 9-5) or page her (#
) 24 hours a day, 7 days a week with 
questions about this research study. You can also call Margaret Lippincott, M.D. at 
 (Monday-Friday 9-5) or page her (
 pager # 
) 24 hours a day, 7 days a 
week with questions about this research study. 
If you have questions about the scheduling of appointments or study visits, call 
 or 
email mghkisspeptinresearch@partners.org.
If you want to speak with someone not directly involved in this research study, please contact 
the Partners Human Research Committee office.  You can call them at 857-282-1900.
You can talk to them about:
▪
Your rights as a research subject
▪
Your concerns about the research
▪
A complaint about the research
Also, if you feel pressured to take part in this research study, or to continue with it, they want to 
know and can help.
If I take part in this research study, how will you protect my privacy?
During this research, identifiable information about your health will be collected.  In the rest of 
this section, we refer to this information simply as “health information.”  In general, under 
federal law, health information is private.  However, there are exceptions to this rule, and you 
should know who may be able to see, use, and share your health information for research and 
why they may need to do so.   
In this study, we may collect health information about you from:
•
Past, present, and future medical records
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 11 of 14
Subject Identification
•
Research procedures, including research office visits, tests, interviews, and 
questionnaires
Who may see, use, and share your identifiable health information and why they may 
need to do so:
•
Partners research staff involved in this study
•
The sponsor(s) of this study, and the people or groups it hires to help perform this 
research
•
Other researchers and medical centers that are part of this study and their ethics boards
•
A group that oversees the data (study information) and safety of this research
•
Non-research staff within Partners who need this information to do their jobs (such as for 
treatment, payment (billing), or health care operations)
•
The Partners ethics board that oversees the research and the Partners research quality 
improvement programs.
•
People from organizations that provide independent accreditation and oversight of 
hospitals and research
•
People or groups that we hire to do work for us, such as data storage companies, insurers, 
and lawyers
•
Federal and state agencies (such as the Food and Drug Administration, the Department of 
Health and Human Services, the National Institutes of Health, and other US or foreign 
government bodies that oversee or review research) 
•
Public health and safety authorities (for example, if we learn information that could mean 
harm to you or others, we may need to report this, as required by law)
•
Other:  researchers and medical centers that may do similar research in the future.
Some people or groups who get your health information might not have to follow the same 
privacy rules that we follow and might use or share your health information without your 
permission in ways that are not described in this form.  For example, we understand that the 
sponsor of this study may use your health information to perform additional research on various 
products or conditions, to obtain regulatory approval of its products, to propose new products, 
and to oversee and improve its products’ performance.  We share your health information only 
when we must, and we ask anyone who receives it from us to take measures to protect your 
privacy.  The sponsor has agreed that it will not contact you without your permission and will not 
use or share your information for any mailing or marketing list.  However, once your information 
is shared outside Partners, we cannot control all the ways that others use or share it and cannot 
promise that it will remain private.
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 12 of 14
Subject Identification
Because research is an ongoing process, we cannot give you an exact date when we will either 
destroy or stop using or sharing your health information.
The results of this research study may be published in a medical book or journal, or used to teach 
others.  However, your name or other identifying information will not be used for these purposes 
without your specific permission.
Your Privacy Rights
You have the right not to sign this form that allows us to use and share your health information 
for research; however, if you don’t sign it, you can’t take part in this research study.   
You have the right to withdraw your permission for us to use or share your health information 
for this research study.  If you want to withdraw your permission, you must notify the person in 
charge of this research study in writing.  Once permission is withdrawn, you cannot continue to 
take part in the study.
If you withdraw your permission, we will not be able to take back information that has already 
been used or shared with others.
You have the right to see and get a copy of your health information that is used or shared for 
treatment or for payment.  To ask for this information, please contact the person in charge of this 
research study.  You may only get such information after the research is finished. 
Informed Consent and Authorization
Statement of Person Giving Informed Consent and Authorization
▪
I have read this consent form.
▪
This research study has been explained to me, including risks and possible benefits (if 
any), other possible treatments or procedures, and other important things about the study.
▪
I have had the opportunity to ask questions.
▪
I understand the information given to me.
Signature of Subject:
I give my consent to take part in this research study and agree to allow my health information to 
be used and shared as described above.
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 13 of 14
Subject Identification
Subject
Date
Time (optional)
Signature of Study Doctor or Person Obtaining Consent:
Statement of Study Doctor or Person Obtaining Consent
▪
I have explained the research to the study subject.
▪
I have answered all questions about this research study to the best of my ability.
Study Doctor or Person Obtaining Consent
Date
Time (optional)
Consent of Non-English Speaking Subjects Using the “Short Form” in the 
Subject’s Spoken Language
Statement of Hospital Medical Interpreter
As someone who understands both English and the language spoken by the subject, I interpreted, 
in the subject's language, the researcher's presentation of the English consent form.  The subject 
was given the opportunity to ask questions.
Hospital Medical Interpreter
Date
Time (optional)
OR
Statement of Other Individual (Non-Interpreter)
As someone who understands both English and the language spoken by the subject, I represent 
that the English version of the consent form was presented orally to the subject in the subject’s 
own language, and that the subject was given the opportunity to ask questions.
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50


Partners HealthCare System
Research Consent Form
General Template
Version Date:  August 2016
Page 14 of 14
Subject Identification
Name
Date
Time (optional)
Permission for Future Contact
We may want to contact you about additional studies in the future.  Do you give permission 
for us to contact you about future studies? 
⁭ YES, I give permission to be contacted about future studies.
⁭ NO, I do NOT wish to be contacted about future studies. 
Subject
Date
Consent Form Version:  6/20/2023
IRB Protocol No: 2016P002281
IRB Expiration Date: 11/29/2023
Consent Form Valid Date: 6/21/2023
IRB Submission: AME50