A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Normal Menstruating Women
Phase: PHASE2
Conditions: Pregnancy Prevention
Sponsor: InnovaGyn, Inc.

Cover Page:  
Title:  A Phase II study to evaluate the delay in ovulation following oral levonorgestrel plus 
meloxicam compared to placebo in normal menstruating women  
NCT number:    NCT05695352  
Document date:   November 8, 2021 
Study Protocol: 
1. Objective: This clinical trial determines 1) if an oral medication taken within 2 
days of anticipated ovulation will delay ovulation by 7 days, 2) compare the 
incidence of unscheduled bleeding and interval between menses, 3) evaluate 
sitting blood pressure between cycles with placebo compared to treatment, and 
4) treatment emergent adverse events between a placebo and a treatment cycle 
in normal menstruating women. 
2. Design:  The study compares placebo tablets (control) to a combination of 
levonorgestrel, a synthetic hormone plus meloxicam, a non-steroidal anti-
inflammatory drug (treatment) in 22 healthy women between the ages of 18 to 
40. The control and treatments are each taken orally 48 hours apart in the first 
and second menstrual cycle, respectively when the ovarian follicle has a 
diameter of 17 ± 1.0 mm measured by transvaginal ultrasound. This follicle 
diameter is found 2 ± 1.0 days before ovulation. Each study participant has 
approximately 9 visits during each of two menstrual cycles. The visits are 
between 3 to 6 from menstrual day 9 (first visit) to largest follicle depending upon 
follicle growth. A blood sample to measure serum estradiol and luteinizing 
hormone and a transvaginal ultrasound to measure ovarian follicle diameter are 
obtained at each visit. The appropriate first dose of medication (placebo first 
cycle and levonorgestrel plus meloxicam in the second cycle) is taken when the 
largest diameter of the lead ovarian follicle is 17 ± 1.0 mm in any dimension. The 
second dose is taken 2 days later with interim and final visits at 5 and 10 days 
following first dose. Each participant collects 4.0 mL of her first morning urine 
from menstrual day 9 to 23. This aliquot of morning urine is placed in a labelled 
storage tube and kept in the refrigerator freezer section until returned to the 
clinical site at a scheduled visit and stored frozen until analyzed a central 
laboratory.  
3. Methods:  Ovulation is determined using the change in ratio of the urinary 
metabolites of estradiol and progesterone known as the Day of follicular-Luteal 
Transition (DALT). The estradiol and progesterone metabolites are estrogen 
glucuronide and pregnanediol glucuronide, respectively. They are measured in 
the urine using specific antibodies to each metabolite using a specific ELISA kit. 
A published algorithm based on a moving day to day average of the metabolites 
ratio is used to determine the day of ovulation (DALT).   The Investigators 
anticipate that the control cycle will have an interval to ovulation of ≤ 3 days from 
the first placebo dose to ovulation while a delay of ≥7 days will be found between 
the first treatment dose to ovulation. Treatment emergent side effects between 
control versus treatment cycles are based on symptoms such as nausea or 

abdominal cramping, change in sitting blood pressure and the interval between  
menstrual bleeding and /or unscheduled bleeding between menses. 
4. Outcomes: The primary outcome compares the interval in days from first dose 
of each medication to ovulation between placebo and treatment. Secondary 
outcomes are changes in mean blood pressure, unscheduled vaginal bleeding, 
and interval between menstrual periods, adverse events such as nausea, 
headache, and abdominal and /or menstrual cramps in placebo cycle compared 
to the treatment cycle. 
5. Statistical Analysis:  We expect that two doses of a levonorgestrel plus meloxicam 
combination, dosed 48h apart with the first dose administered when the dominant follicle 
has reached 17±1.0 mm in size, will result in the “Day of follicular-Luteal Transition” 
(DALT) being delayed by at least 7 days vs the time to DALT ≤3 days when a woman 
received two doses of placebo. The DALT following determination of the ratios of the 
urinary metabolites of estrone conjugates and progesterone will be identified using 
published algorithms. Survival analysis/LogRank method was applied to calculate the 
required sample size. The outcome event is the time until ovulation (DALT) and censored 
observations (subjects for whom ovulation did not occur during the 10-day follow-up time) 
are probable. The aim is to compare the survival curves for the 2-doses placebo to the 2-
doses treatment group using the length of follow-up for each patient and the Log-Rank 
Test. The Null Hypothesis is that there will be no significant difference between the two 
survival curves. The sample size is obtained for a power of 80% and a two-sided test size 
alpha of 5%. We assume that the ovulation rate in the placebo group is approximately 
95% by 10 days after the first dose of placebo. If we want to increase the success rate 
(failure to ovulate) from 5% in the placebo group to 80% in the treatment group by 10 days 
after the first dose of drug combination, we will need to recruit to complete 22 subjects. 
We plan to enroll 26 or more participants to complete a minimum of 22 participants in this 
study. 
Informed Consent: 
 
 
Participant Consent Form And 
Authorization to Use and Disclose Protected Health Information 
 
Sponsor / Study Title: 
  
InnovaGyn, Inc. / “A Phase II study to evaluate the delay in 
ovulation following oral levonorgestrel plus meloxicam 
compared to placebo in normal menstruating women” 
 
Protocol Number: 
 
IG-20-001 
 
Principal Investigator: 
(Study Doctor) 
 
«PiFullName» 
 
Telephone: 
 
«IcfPhoneNumber» 
 

Address: 
«PiLocations» 
 
 
 
KEY SUMMARY OF INFORMATION 
You are invited to take part in a research study evaluating levonorgestrel plus meloxicam 
(LNG/MEL) as a possible “on-demand” contraceptive, sponsored by InnovaGyn, Inc. The use of 
LNG/MEL in this study is investigational. An investigational use is one that is not approved by 
the United States Food and Drug Administration (FDA). It is important that you do not become 
pregnant while in the study; you must use effective methods of birth control throughout the 
study. This page provides key information to help you decide whether to participate. The 
detailed consent form follows this page. If you have questions, please ask the research team, or 
contact the principal investigator in charge of this study. 
 
WHAT IS THE PURPOSE, WHAT ARE THE PROCEDURES, AND WHAT IS THE DURATION OF THIS 
STUDY? 
The purpose of this study is to find out if ovulation is delayed when using LNG/MEL compared 
to placebo (inactive substance); if there are any effects of the LNG/MEL study drug on 
menstrual periods and unscheduled vaginal bleeding; the effects the study drug has on the 
function of the ovaries and uterus; if there are side effects from this study drug; if the side 
effects from this study drug are more or less serious than the side effects from other hormonal 
contraceptives. Your total time in the study is expected to include up to 18 visits over 3 months, 
including a screening period, control cycle, study treatment cycle, and follow up after the end 
of study treatment. The exact number of site visits is unknown. 
 
WHAT ARE SOME REASONS YOU MIGHT CHOOSE TO PARTICIPATE IN THIS STUDY? 
You will receive medical and gynecological exams, laboratory assessments and satisfaction of 
participating in the possible development of a new “on-demand” contraceptive option for 
women. You will receive compensation for travel and costs that are associated with 
participation in the study. 
 
WHAT ARE SOME REASONS YOU MIGHT CHOOSE NOT TO PARTICIPATE IN THIS STUDY? 
You might choose not to participate in this study if you have any health problems or conditions 
or are taking any medicines with contraindications to the study drug and study requirements, 
or if you are planning to become pregnant. You will need to consider the exposure to research 
related risks as well as potential side effects. For a complete description of the risks of this 
study, please refer to the detailed consent form. 
 
DO YOU HAVE TO TAKE PART IN THIS STUDY? 
Participation in this study is voluntary. If you do not want to be in this study, you will still 
receive any of the services otherwise available to you at this study site. You are free to 
withdraw from the study at any time. 
 
WHAT IF YOU HAVE QUESTIONS OR CONCERNS? 
For questions about the study, contact the investigator at the phone number listed on page one 
of this form.  

 
Please continue for detailed information about the study. 
 
SPONSOR 
The costs of this study, including administrative fees paid to the investigator(s), are being paid 
by InnovaGyn, Inc., who developed the experimental on-demand contraceptive containing 
levonorgestrel and meloxicam being studied. 
 
WHY IS THIS STUDY BEING DONE? 
The purpose of this study is to find out: 
• If ovulation is delayed when using LNG/MEL compared to placebo. 
• If there are any effects of the LNG/MEL study drug on menstrual periods and 
unscheduled vaginal bleeding. 
• The effects the study drug has on the function of the ovaries and uterus. 
• If there are side effects from this study drug that are different from what we know 
about side effects from other hormonal contraceptives.  
• If the side-effects from this study drug are more or less serious than the side-effects 
from other hormonal contraceptives 
• Sexually experienced women have indicated a need for a discreet oral product that is a 
highly effective contraceptive method with limited side effects, to be taken immediately 
before or after intercourse. This approach has been termed on demand or pericoital 
contraception when the product is taken within 24 hours before or after intercourse.  
This method reduces the need for motivation to take continuous oral medication and 
potentially reduces the exposure to daily exogenous hormones used with long-acting 
reversible methods.   
 
WHY ARE YOU BEING ASKED TO TAKE PART? 
You are being asked to participate in this research project because you are a woman who is 
generally healthy with no chronic medical conditions, 18 through 40 years old, have a regular 
menstrual cycle that starts every 24-32 days, and have a uterus and both ovaries. 
 
This is a research study. This study includes only people who choose to take part. Please take 
your time to make your decision and feel free to ask any questions you might have. 
 
WHAT ARE SOME IMPORTANT DETAILS ABOUT THIS STUDY? 
At this local site 22 people will take part in this study at one (1) site in the United States. We will 
need you to be in the study for approximately 3 months. 
 
Clinically relevant research results will not be disclosed to participants. 
 
WHEN SHOULD YOU NOT TAKE PART? 

To join the study, you should not be pregnant and must not have had any unprotected 
heterosexual intercourse during the previous 10 days. If you have intercourse you or your 
partner should use a condom, or diaphragm, or you could have a copper intrauterine device for 
contraception. You should not currently be using hormonal contraception (a pill, vaginal ring, 
patch, or injection and the levonorgestrel releasing intrauterine device). Also, you must 
understand what is required to take part in the study and be willing to meet the study 
requirements. 
 
If you have any of the following health problems or conditions or are taking any of the 
medicines listed below, you should not take part in this study: 
1. Known hypersensitivity or allergies to progestins and non-steroidal anti-inflammatory 
drugs such as Advil/Ibuprofen. 
2. Abnormal transvaginal ultrasound or safety laboratory results evaluated during the 
screening period recognized as clinically significant by the investigator or medically 
qualified designee. 
3. Known or suspected alcohol or marijuana abuse. 
4. Undiagnosed abnormal genital bleeding. 
5. Undiagnosed vaginal discharge, lesions, or abnormalities. Potential participants 
diagnosed with Chlamydia or Gonorrhea at screening may be included in the clinical 
study if treatment was completed.  Women with a history of genital herpes can be 
included if the outbreaks are infrequent and antiviral prophylaxis is allowed if used. 
6. Uncontrolled thyroid disorder. 
7. Current use of hormonal contraception or a levonorgestrel releasing intrauterine device. 
8. Use of a long-acting injectable hormonal contraceptive within the past 6 months and 
must have had at least one spontaneous menstrual cycle (two menstrual bleeding 
episodes) since the last injection.  
9. Breastfeeding women or those within 30 days of discontinuing breast-feeding or those 
who have discontinued and had not had a spontaneous menstrual bleed. 
10. Women who plan a major surgical procedure during the study. 
11. Women (couples) who plan to become pregnant during the months of the study 
procedures. 
12. Women who smoke greater than 15 cigarettes per day or who use greater than 1 
mL/day of nicotine-containing liquid for electronic cigarettes should be evaluated for 
the impact of this use on its impact on increasing the risk of cardiovascular disease and 
thromboembolism. 
13. Current or history of ischemic heart disease or stroke while pregnant or during use of 
hormonal contraception. 
14. Current or past deep vein thrombosis (blood clot) or thromboembolic disorder. 
15. History of thrombophilia in a first degree relative less than 45 years of age suggesting a 
defect in the blood coagulation system. The Principal Investigator’s opinion of the risk 
with hormonal contraception should be considered. 
16. History of retinal vascular lesions, partial or complete loss of vision. 
17. Known or suspected cancer of the breast, endometrium, or other suspected progestin 
sensitive neoplasia. 

18. History of other carcinomas excluding basal cell cancers unless in remission for greater 
than 5 years. 
19. Current or past medically diagnosed severe depression unless the potential participant 
is on stable medication and in the opinion of the Principal Investigator could be 
exacerbated using a hormonal contraceptive. 
20. History of headaches with focal neurologic symptoms. 
21. Have a current need for exogenous hormones or therapeutic anticoagulants. 
22. History of jaundice during a pregnancy or jaundice with prior steroid hormone use. 
23. Other benign or malignant liver tumors or active liver disease. 
24. Systolic blood pressure (BP) greater than or equal to 145 mm Hg and /or diastolic BP 
greater than or equal to 96 mm Hg after 5 -10 minutes of rest in a sitting position. 
Systolic BP greater than 145 mm Hg and/or diastolic BP greater than 95 mm Hg is 
exclusionary.  If the initial BP values are above these cut-offs a total of 3 measurements 
may be taken and the results averaged.  If the average BP is below the cut off levels the 
participant may be allowed into the study.  Hypertension that is treated and controlled 
may in the judgment the Investigator are good candidates for the study require a 
waiver. 
25. Clinically significant abnormal blood chemistry values of liver or kidney function based 
on the Investigator judgement. 
26. Participation in another clinical trial involving an investigational drug or device within 
the past two months before anticipated enrollment or is planning to participate in 
another clinical study during this study. 
27. Use of any liver enzyme inducers or plans to use such medication during the study (See 
Appendix). 
28. Known HIV infection. 
29. History of a gastrointestinal ulcer or bleeding. 
30. Women who are using medication on the exclusionary medication list (See Appendix). 
31. Have issues or concerns in the opinion of the Investigator that may compromise the 
study or confound the reliability of compliance and information that is required in this 
study. 
32. Have a known hypersensitivity to either levonorgestrel or a non-steroidal anti-
inflammatory drug. 
33. Use of any medication that could interfere with the metabolism of a hormonal 
contraceptive or the non-steroidal anti-inflammatory drugs or any drug that falls in FDA 
Pregnancy and Lactation narrative subsections (Formerly Category D or X medications) 
34. Be a site member with delegated study responsibilities or a family member of, or have a 
close relationship with, a site staff member will be delegated study responsibilities. 
 
WHAT IS INVOLVED IN THE STUDY? 
Your total time in the study is expected to last up to 3 months. The screening period will be 
approximately 2 weeks, the control cycle will be 1 month, the study treatment cycle will be 1 
month, and follow up will occur approximately 3 weeks after the end of study treatment. The 
exact number of site visits is unknown as the study drug is given based on the largest size of the 
ovarian follicle (cyst) reaching a pre-determined size using a transvaginal ultrasound scan of 

your ovaries. It is estimated there will be approximately 18 scheduled visits over 3 months that 
will need to be completed during the study.  
 
During the study, a total of approximately 100 mL of blood (about 20 teaspoons or less than 
one-half of a cup) will be drawn from you over 3 months. The most blood drawn in a single day 
will be 18 mL, or less than 4 teaspoons. You will be asked to collect your first morning urine 
from menstrual day 9 to 23 and place a teaspoonful of this urine in a vial for storage. The vial is 
kept frozen in your refrigerator until returned to the clinical site. 
 
If you are enrolled and agree to participate, you must not be at risk of becoming pregnant for 
your entire time of study participation. If you are sexually active in a heterosexual relationship, 
either your partner must be surgically sterile with a vasectomy, you must have previously had 
your tubes tied (tubal ligation) or you must use another non-hormonal method of birth control 
to prevent pregnancy (such as condoms, diaphragm plus spermicide, or a copper IUD). 
 
Once you have decided to participate in the study, you will first be sent the informed consent to 
review before your scheduled appointment.   This should provide a minimum of 24 hours 
before your appointment in order to read and consider participation in the study. On the day of 
your first visit you will be asked to sign and date this Informed Consent Form indicating you 
have read and understood the study and all of your questions have been answered before any 
study procedures will be done.   
If you agree to be in this study, you will be asked to give your consent by signing and dating this 
form. Participation is expected to consist of approximately 18 study visits over 3 months. The 
details of these visits are described below. A table of these visits has also been provided later in 
this form. 
At most visits, study staff will review your study diary, in which you will be asked to record daily 
occurrence of vaginal bleeding or spotting and collect vital signs. At pre-study treatment visits 
and during each menstrual cycle, you will have your blood drawn and a pelvic ultrasound (US) 
test will be performed. At post-study treatment visits you will drop off your daily morning urine 
collection.  
During visits where blood is drawn (screening and pre-study treatment) about 1-3 teaspoons of 
blood will be drawn. During the study a total of approximately 100 mL of blood (about 20 
teaspoons or less than one-half of a cup) will be drawn. Urine pregnancy tests will be 
performed at screening, at your first control cycle visit and your first study treatment cycle visit. 
This test must be negative in order for you to continue in the study. 
 
You will have one screening visit. This visit will occur between the twentieth and twenty-fourth 
day (20th and 24th day) of your menstrual cycle. The following will occur at the first visit:  
 

1. Read the informed consent form and ask questions about things you do not understand. 
Before you sign and date the consent form, make sure you understand what this study is 
about and what you will be asked to do. 
 
2. The study site staff needs to make sure the study is right for you. They need to obtain 
the following: 
a. Information about you, including your date of birth, ethnicity, and race. 
b. Your medical history, including all past and current medical problems, surgeries and 
gynecological (female reproductive) history. The information collected will include 
smoking history, history of alcohol or drug use (if you have used either), menstrual 
cycle history, pregnancy history and current sexual activity information. 
c. Your family history of certain health conditions like blood clots. 
d. Your blood pressure will be measured after you have rested by sitting for 5-10 
minutes. It will be measured three times with a five-minute rest period between the 
measurements. 
e. Your pulse, weight, and height will be recorded. The study staff will tell you what 
your body mass index (BMI) is.  
f. Tell the study staff about the medicines you are taking or have taken in the previous 
two weeks. This includes prescriptions, over-the-counter medicines, vitamins, and 
herbal products. 
g. You will have a complete physical examination, including a breast exam, a pelvic 
exam (internal female exam), and a cervical Pap smear (unless you have had one 
recently and the study doctor can obtain the results, or if you are under 21 years 
old). You will also be screened for Gonorrhea, Chlamydia and Trichomonas. 
 
During the pelvic exam, you will lie on your back with your feet in stirrups. Your 
study doctor will insert a speculum into your vagina. The speculum gently spreads 
apart the vaginal walls, allowing your study doctor to see the inside of the vagina 
and the cervix (opening to the womb). You may feel some slight discomfort when 
the speculum is placed. Swabs will be used to collect samples from your vagina and 
cervix for testing.   
 
A pelvic ultrasound (US) test will be performed. Before the study procedure, you will 
be asked to empty your bladder. For the ultrasound, the tip of a small, thin 
ultrasound instrument (probe) is lubricated with a small amount of gel and inserted 
in your vagina. Only two to three inches of the instrument are inserted into the 
vagina. Ultrasound imaging uses sound waves to produce pictures of the inside of 
the uterus and ovaries. The ultrasound pictures will be shown on a computer 
monitor. The study doctor will be looking at the thickness of the endometrium 
(lining of the womb) and number and size of ovarian follicles (fluid filled sacs located 
just beneath the ovary’s surface that contain the immature eggs). 
 
The Pap test is a test of a sample of cells taken from a woman's cervix (opening of 
the womb). This test is used to look for changes in the cells of the cervix that show 

cervical cancer or conditions that may develop into cancer. If you are due for a Pap, 
this test will be done while the speculum is inserted during the pelvic exam. If you 
have a vaginal infection, you may be given medicine for it before you can enroll in 
the study. 
h. Regular blood and urine tests, including urine pregnancy tests. 
i. You will be given a diary to fill out and instructions on urine collection.  
 
After the screening visit is complete, you will contact your study coordinator on the first day of 
your next menses. Your study coordinator will schedule you to come in on the ninth day (9th 
day) of your menstrual cycle to begin the control/study treatment cycle procedures. Refer to 
the visit flow chart below for additional information. 
 
Appendix: On Demand Visit Flow Chart 
 
Screena 
Control 
Cycle Pre-
Study 
Treatment 
Visits b 
Control 
Cycle 
DOSE 
1c 
Control 
Cycle 
DOSE 
2d 
End of 
Cycle 
Urine 
Collection 
CD 22 
Study 
Treatment 
Cycle Pre-
Study 
Treatment 
Visitsb 
Study 
Treatment 
Cycle 2 
DOSE 1c 
Study 
Treatment 
Cycle 2 
DOSE 2d 
End of 
Cycle 
Urine 
Collection 
EXIT 
visitᴴ 
Procedures 
 
 
 
 
 
 
 
 
 
 
Informed 
Consent 
Form (ICF) 
X 
 
 
 
 
 
 
 
 
 
Med HX 
X 
 
 
 
 
 
 
 
 
 
Con Med 
X 
X 
 
X 
X 
X 
 
 
X 
X 
Adverse 
Events (AEs) 
X 
X 
 
X 
X 
X 
 
 
X 
X 
Vitalse 
X 
X 
 
X 
X 
X 
 
 
X 
X 
Height and 
Weight 
X 
 
 
 
 
 
 
 
X 
 
Complete 
blood count 
(CBC) 
X 
 
 
 
 
 
 
 
 
 
Chemistries 
X 
 
 
 
 
 
 
 
 
 
P4 
X 
 
 
 
 
 
 
 
 
 
Estradiol 
 
X 
 
 
 
X 
 
 
 
 
Luteinizing 
hormone 
 
X 
 
 
 
X 
 
 
 
 
Physical 
Examination 
X 
 
 
 
 
 
 
 
 
 
Urine 
Pregnancy 
Test (UPT) 
X 
X 
 
 
 
X 
 
 
 
X 
Transvaginal 
Ultrasound 
(TVU) 
X 
X 
 
 
 
X 
 
 
 
 
Study Drug 
Dispensing 
 
 
X 
X 
 
 
X 
X 
 
 

Daily Urine 
Collectionᶠ 
 
X 
 
 
X 
 
 
 
X 
 
Dispense 
Diary and 
Collectᴳ 
 
X 
 
 
 
X 
 
 
X 
X 
a Screening to occur on CD 20-24 
b Pre-study treatment visits will start on CD 9. Frequency and number of visits is dependent on follicle monitoring and up to the 
discretion of the PI. Each visit has a blood draw for estradiol and luteinizing hormone and a transvaginal ultrasound for uterine 
stripe and ovarian follicle size. 
c Initial dose will occur when dominant follicle measures 17±1.0 mm in the largest diameter and after all pre-study treatment 
visit procedures are completed 
d Second dose to occur 48 hours after initial dose 
e Vitals consist of sitting blood pressure and pulse  
ᶠ Collect daily first void morning urine beginning cycle day 9 and ending 10 days after first dose. Aliquot urine into supplied 
capped tube and refrigerate. 
ᴳ Dispense daily diary at first visit day 9 in both cycles and collect on second cycle day 9 and at exit visit. 
ᴴ Exit visit between day 5 to 10 after study treatment cycle 2 menstrual bleed. 
 
WHAT ARE THE RISKS OF THE STUDY? 
You may have some side effects we do not expect because we are still learning about this study 
drug. The side effects listed below have been reported in people who used LNG (levonorgestrel) 
in pills, implants or IUDs (intrauterine devices). LNG is a drug that is similar to LNG/MEL study 
drug. Because the LNG is the active component of LNG/MEL in the body, we expect that the 
side effects from LNG/MEL will be similar to those seen in women using LNG.  MEL (meloxicam) 
can cause indigestion, nausea, vomiting or bleeding from your bowel.  Meloxicam has also been 
associated with heart attacks, blood clots in the leg, and stroke, mainly in older men and 
women. There may be other unknown side effects of the LNG/MEL study treatment.  
 
It is not known if a woman using this LNG/MEL study treatment is at a higher risk of serious side 
effects than she would be if she used an FDA approved birth control.  
 
Risks and side effects related to the LNG/MEL study drug may include: 
• Irregular menstrual spotting or bleeding 23% 
• More frequent or prolonged or heavy bleeding 30.9% 
• Frequent onset of bleeding and/or very light or absent menstrual bleeding 52% 
• Headache 12% 
• Vaginal irritation/inflammation 20% 
• Breast tenderness or pain 8.2% 
• Abdominal pain 13.3% 
• Mood changes 4% 
• Nausea 13.7% 
• Acne 15% 
• Discomfort with menstruation 9% 
• Back or pelvic pain 6% 
• Elevations in liver function tests 1% 
 
Less likely side effects may include: 

• Migraine headache 2% 
• Abnormal hair growth (increased hair growth and/or hair loss) 1% 
• Pelvic cramping 6% 
• Ovarian cysts symptoms include:  13% 
o Pelvic pain 
o Nausea 
o Vomiting 
o Fullness in the abdomen 
o Pressure on your rectum or bladder 
 
Rare but serious side effects may include: 
• Severe allergic reactions less than 1%. Symptoms may include: 
o Rash 
o Hives 
o Itching 
o Difficulty breathing 
o Tightness in the chest 
o Swelling of the mouth, face, lips, or tongue 
 
Meloxicam is a well-known non-steroidal anti-inflammatory drug (NSAID) used to treat and 
reduce the pain of arthritis. It is principally taken daily by older men and women for chronic 
arthritic or muscular pain. There is an increased risk of cardiovascular disease such as deep vein 
thrombosis and myocardial infarction with chronic daily administration of non-steroidal anti-
inflammatory drugs that is also age related.  Gastric ulcers and gastrointestinal bleeding are 
associated with chronic administration of an NSAID at any age.  Skin reactions are infrequent 
but can be life threatening. Stevens Johnson Syndrome and Toxic epidermolysis are rare but 
can have serious or fatal side effects.  Common side effects occurring in more than 5% of users 
are: 
• Diarrhea 7.8% 
• Upper respiratory tract infection 6.1% 
• Dyspepsia (indigestion) 4.45% 
• Influenza like symptoms 5.8% 
 
You should contact your study staff and study doctor immediately if any of these serious events 
occur. If your study doctor cannot be reached, you should seek medical treatment at the 
nearest medical facility available to you. 
 
There may be other side effects that are unknown and that we cannot predict.  
 
WHAT ARE THE RISKS OF THE STUDY PROCEDURES? 
• Blood Collection (Venipuncture): Venipuncture is taking blood from a vein by needle. 
There is a risk of fainting, infection, bruising, swelling and pain at the site of the blood 

drawing. Blood samples will be taken with each ultrasound visit. Fasting blood samples 
will be taken at the screening visit. 
• Gynecological Exams and Pap Smears: Gynecological exams and pap smears may cause 
some slight pain or cramping. Some women may experience temporary spotting or 
bleeding afterward. 
• Diary, Acceptability Questionnaire and Medical History Questions: Some of the 
questions you will be asked may seem personal or embarrassing. They may upset you. 
You may refuse to answer any of the questions that you do not wish to answer. If the 
questions make you very upset, we will help you find a counselor.  
 
A risk associated with allowing your data to be saved is the release of personal information 
from your study record.  We will strive to protect your records so that your personal 
information (like name, address, social security number and phone number) will remain private. 
 
While on the study, you are at risk for these side effects. You should discuss these with the 
investigator and/or your regular doctor or healthcare provider. Other drugs may be given to 
make side effects less serious and make you more comfortable. Many side effects go away 
shortly after the LNG/MEL is stopped, but in some cases side effects can be serious, long lasting 
and/or permanent.  
Reproductive risks: Because the study drugs in this study can affect an unborn baby, you should 
not become pregnant while on this study. You should not breastfeed your baby while on this 
study. Ask about counseling and more information about preventing pregnancy.  Acceptable 
methods of birth control include: either your partner must be surgically sterile with a 
vasectomy or you must have previously had your tubes tied (tubal ligation) or you must use 
another non-hormonal method of birth control to prevent pregnancy (such as condoms, 
diaphragm plus spermicide, or copper IUD).  You will have to use one of these methods the 
whole time you are in this study. You should consider this before you decide to take part in this 
study. This study is NOT intended to find out how well the study drug works to prevent 
pregnancy, so if you are sexually active with a male partner, you must use other means of birth 
control while you are in the study. 
 
The LNG/MEL study treatment should not be considered a form of birth control.  The LNG/MEL 
study treatment must not be relied upon as a method of birth control. To take part in this 
study, you must not be at risk of becoming pregnant. You do not have to be sexually active to 
take part in this study. 
 
Talk to the study doctor or study nurse about what you might do if you become pregnant and 
do not wish to continue the pregnancy. If you become pregnant, LNG has not been shown to 
affect the fetus.  MEL has inconclusive information on early pregnancy, but near delivery it can 
affect the fetus only if you continue to take it during the pregnancy.  You should understand 
what you could do before you give consent to take part in this study. 
 

If you become pregnant during the study, you will be discontinued from the study and 
complete the study procedures for the Exit Visit. You will be informed about pregnancy options 
and referral for appropriate care. The study staff will monitor the pregnancy until the 
pregnancy outcome is known or 6- or 12-month follow-up after delivery. The study staff will 
attempt to estimate the date of conception by performing a pelvic ultrasound and/or pelvic 
and/or abdominal examination and by looking at your diary information and blood hormone 
levels. 
 
For more information about risks and side effects, ask the investigator. 
 
ARE THERE BENEFITS TO TAKING PART IN THE STUDY? 
If you agree to take part in this study, there may or may not be a direct benefit to you. There is 
no guarantee that you will personally benefit from taking part in this study. We hope the 
information learned from this study will benefit other women with the development of a new 
“on-demand” contraceptive option in the future. 
 
WHAT ABOUT CONFIDENTIALITY? 
In conducting this research study, it may be necessary for the research team to send 
information about you and your health to persons in other organizations.  For example, the 
investigator  or members of the research team will report the results of your study-related data 
to InnovaGyn, Inc., the sponsor of the study.  This information may include what we call 
“protected health information (PHI),” which includes personal information about you. It will be 
shared with others only as described below:   
 
Description of Your 
PHI to Be Disclosed 
Organization and 
Person (or their title) 
Disclosing Your PHI  
Organization and 
Person (or their 
title) Receiving 
Your PHI  
Purpose of 
Disclosure 
Name, 
Social Security #, 
Participant #, 
Initials 
Investigator and/or 
research center  
David F. Archer, 
MD and 
InnovaGyn, Inc. 
Identification and 
reporting laboratory 
results and issuance 
of an IRS 1099 form 
for reimbursed for 
participating in the 
study 
Date of Birth, 
Demographics, 
Medical History and 
Acceptability 
Questionnaire 
Investigator and/or 
research center  
David F. Archer, 
MD and 
InnovaGyn, Inc. 
Data management 
and analysis; To 
protect the rights 
and safety of 
participants  and 
make sure applicable 
laws are followed 
 

All protected health information will be maintained in strict confidence as required by law. 
However, your protected health information may be disclosed if required by law.  Once your 
protected health information is disclosed for research, such as to the sponsor, federal privacy 
laws may no longer protect the information. 
 
• If you refuse to give your approval for your personal information to be shared as 
described in this consent form, you will not be able to be in this study.  However, your 
choice will not affect any medical benefits to which you are entitled. 
• By signing and dating this consent form to participate in the study, you are allowing the 
research team to share PHI, as described in this consent form.  
• You have the right to cancel your approval for the sharing of PHI. If you cancel your 
approval, you will have to leave the study.  All information collected about you before 
the date you cancelled will not be used.  To cancel your approval, you must notify the 
investigator.  
• Your approval for the sharing of personal information about you for this study does not 
expire at the end of the study. 
• You also have the right to review your research records, or someone you designate may 
review your research records on your behalf once the study has ended unless prohibited 
by law. 
• Any research information in your medical record will become a permanent part of that 
document. 
 
Your study records may be reviewed and/or copied in order to meet state and/or federal 
regulations.   Reviewers may include, for example, the Institutional Review Board, 
Representatives of InnovaGyn Inc., The Food and Drug Administration (FDA) and other US 
governmental agencies, Government agencies to whom certain diseases (like HIV, hepatitis, and 
STDs) must be reported, Governmental agencies of other countries, Labs working with the 
sponsor on this study, and other authorized users. 
 
To ensure that your information collected for this study will be kept private, your name will not 
be used whenever possible.  A code will be used instead of your name. All of your study data 
will be kept in a secure location. 
 
Your health data needs to be shared for the research and other reasons. Therefore, complete 
privacy of your health data cannot be promised. However, sharing your health data will be 
guided by professional standards and the law. 
 
Information from this study may be presented at meetings or published in medical journals.  
The information included at meetings or in journals will not include your name or information 
that can easily be traced back to you.   
 
Information learned from this research may be used in reports, presentations and publications.  
None of these will personally identify you. 

This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, documents, 
or biospecimens that may identify you in any federal, state, or local civil, criminal, 
administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for 
example, if there is a court subpoena, unless you have consented for this use. Information, 
documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else 
who is not connected with the research except, if there is a federal, state, or local law that 
requires disclosure (see below); if you have consented to the disclosure, including for your 
medical treatment; or if it is used for other scientific research, as allowed by federal regulations 
protecting research subjects.  
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by the agency which is funding this project or for information that must be 
disclosed in order to meet the requirements of the federal Food and Drug Administration 
(FDA).  You should understand that a Certificate of Confidentiality does not prevent you from 
voluntarily releasing information about yourself or your involvement in this research. If you 
want your research information released to an insurer, medical care provider, or any other 
person not connected with the research, you must provide consent to allow the researchers to 
release it. 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law of, for instance, child abuse or neglect, harm to self or others, and 
communicable diseases.  
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you 
have consented to in this informed consent document. 
WHAT WILL PARTICIPATION IN THE STUDY COST OR PAY? 
There are no additional costs to you associated with taking part in this study. 
 
You could receive up to $910.00 if all study visits are completed. You will be paid $100 for the 
Screening Visit. At the End of Cycle 1, you will be paid $380. At the end of Cycle 2, which 
includes the Exit Visit, you will be paid $430.  
 
You will be paid following each completed visit (Screening, Cycle 1, and Cycle 2) or at the end of 
your participation in the research study. If you do not finish the study, you will only be paid for 
the visits you completed.  
 
If the amount exceeds $600 within a calendar year, an IRS Form 1099 will be filed with the 
Internal Revenue Service, with a copy going to you. 
 
If any new products, tests, or discoveries resulting from the research have potential commercial 
value, you will not be compensated or benefit financially. 

 
ALTERNATIVES TO PARTICIPATION  
This research study is for research purposes only. The only alternative is to not participate in 
this study. 
 
WHAT IF YOU GET INJURED? 
In the case of injury or illness resulting from this study, please seek emergency medical 
treatment.   Financial compensation for a research related injury or illness, lost wages, 
disability, or discomfort is not available.  However, you do not waive any legal rights by signing 
and dating this consent form. 
 
WHAT ABOUT THE COLLECTION OF DATA/TISSUE/SPECIMENS? 
Researchers can look closely at large amounts of your genetic information by sequencing, or 
“reading,” every letter in your DNA (your genome). Reading a person’s entire genetic code is 
called whole genome sequencing. The research will not include whole genome sequencing (for 
example, sequencing of a human germline or somatic specimen with the intent to generate the 
genome or exome sequence of that specimen). 
 
You are in a study where data and blood samples are collected as part of your participation in 
the research study. These data and blood samples will not be used or distributed for future 
research studies by the investigator or other researchers.  After all of the study testing is 
complete, the data and specimens will be destroyed. 
 
To ensure that your identifiable data collected for this study will be kept private, your name will 
not be used whenever possible.  A code will be used instead of your name.  All your study data 
will be kept in a secure location. Your health data needs to be shared for the research and other 
reasons. Therefore, complete privacy of your health data cannot be promised.  However, 
sharing your health data will be guided by professional standards and the law. For more 
detailed information, please refer to the section of this consent titled “What about 
confidentiality?” 
 
WHAT ARE YOUR RIGHTS AS A PARTICIPANT? 
Taking part in this study is your choice. If you decide not to take part, your choice will not affect 
any medical benefits to which you are entitled. You may choose to leave the study at any time. 
If you do leave the study, discuss it with the investigator who will help you do so in the safest 
way.  If you leave, the study it will not result in any penalty or loss of benefits to you. 
 
The investigator may decide to take you off this study if you cancel your approval or if it is in 
the best interest of your health, if your condition worsens, if funding it stopped, or in the case 
of non-compliance with study requirements. We will tell you about new information that may 
affect your health, welfare, or willingness to stay in this study. 
 
Virginia law says that if you or anyone associated with the study is exposed to the other 
person’s body fluids that might transmit the virus that causes AIDS or the Hepatitis B or C virus: 

• 
The person whose body fluids were involved is deemed to have consented to testing for 
those viruses so that no further consent is necessary to test the person for these 
diseases; and, 
• 
Those test results will be released to the person who was exposed and to the health 
department as required by Virginia law. 
 
WHOM TO CONTACT ABOUT THIS STUDY 
During the study, if you experience any medical problems, suffer a research-related injury, or 
have questions, concerns or complaints about the study, please contact the investigator at the 
telephone number listed on the first page of this consent document. If you seek emergency 
care, or hospitalization is required, alert the treating physician that you are participating in this 
research study.  
 
An institutional review board (IRB) is an independent committee established to help protect the 
rights of research participants. If you have any questions about your rights as a research 
participant, and/or concerns or complaints regarding this research study, contact: 
 
• By mail: 
Study Subject Adviser 
Advarra IRB 
6100 Merriweather Dr., Suite 600 
Columbia, MD 21044 
• or call toll free:    877-992-4724 
• or by email:          adviser@advarra.com 
 
Please reference the following number when contacting the Study Subject Adviser: 
Pro00059583. 
 
FDA CLINICAL TRIAL REGISTRATION 
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. 
 
 
SIGNATURE 
You will get a copy of this signed and dated form. You may also request information from the 
investigator. By signing and dating your name on the line below, you agree to take part in this 
study and accept the risks.   
 
________________________________ 
Typed or Printed Name 
 
_____________________________ 
Signature of Participant 
 
___/___ 
/___ 
MM/ DD/ YY 
 

STATEMENT OF THE INVESTIGATOR OR APPROVED DESIGNEE 
I certify that I have explained to the above individual the nature and purpose of the study, 
potential benefits, and possible risks associated with participation in this study. I have 
answered any questions that have been raised and have witnessed the above signature.  I 
have explained the above to the participant on the date stated on this consent form. 
 
_________________________________________________________ 
Signature of Investigator or Approved Designee 
 
_____ / _____ / 
_____ 
  MM/      DD/       
YY 
 

AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION 
 
If you decide to be in this study, the investigator and study staff will use and share health data 
about you to conduct the study. Health data may include: 
• Your name. 
• Address. 
• Phone number. 
• Date of birth. 
• Medical history. 
• Information from your study visits, including all test results.  
 
Health data may come from your study records or from existing records kept by your doctor or 
other health care workers.  
 
For this study, the study staff may share health data about you with authorized users. 
Authorized users may include: 
• Representatives of InnovaGyn, Inc. 
• Representatives of Advarra IRB (an Institutional Review Board that reviews this study). 
• The Food and Drug Administration (FDA) and other US federal and state agencies. 
• Government agencies to whom certain diseases (like HIV, hepatitis, and STDs) must be 
reported. 
• Governmental agencies of other countries. 
• Outside individuals and companies, such as laboratories and data storage companies, 
who work with the researchers and sponsor and need to access your information to 
conduct this study. 
• Other research doctors and medical centers participating in this study, if applicable.  
• A data safety monitoring board which oversees this study, if applicable.  
 
Your health data will be used to conduct and oversee the research, including for instance: 
• To see if the study drug works and is safe. 
• To compare the study drug to other drugs. 
• For other research activities related to the study drug.  
 
Once your health data has been shared with authorized users, it may no longer be protected by 
federal privacy law and could possibly be used or disclosed in ways other than those listed here.  
 
Your permission to use and share health data about you will end in 50 years unless you revoke 
it (take it back) sooner.  
 
You may revoke (take back) your permission to use and share health data about you at any time 
by writing to the investigator at the address listed on the first page of this form. If you do this, 
you will not be able to stay in this study. No new health data that identifies you will be gathered 

after your written request is received. However, health data about you that has already been 
gathered may still be used and given to others as described in this form.  
 
Your right to access your health data in the study records will be suspended during the study to 
keep from changing the study results. When the study is over, you can access your study health 
data. 
 
If you decide not to sign and date this form, you will not be able to take part in the study. 
 
  
STATEMENT OF AUTHORIZATION  
I have read this form and its contents were explained. My questions have been answered. I 
voluntarily agree to allow study staff to collect, use and share my health data as specified in 
this form. I will receive a signed and dated copy of this form for my records. I am not giving 
up any of my legal rights by signing and dating this form.  
 
 
________________________________ 
Typed or Printed Name 
 
_____________________________ 
Signature of Participant 
 
___/___ 
/___ 
MM/ DD/ YY