Clinical trial NCT05633966: Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Official title: Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hypothalamic Amenorrhea
Hypogonadotropic Hypogonadism
Keywords: Hypothalamic Amenorrhea
Hypogonadotropic Hypogonadism
Kisspeptin
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

Detailed description: Assignment: All study subjects will undergo the same interventions.

Delivery of Interventions:

* The subject will undergo a review of their medical history, physical exam, and screening laboratories.
* A pelvic ultrasound will be performed to assess baseline follicular size.
* A pump will be placed to administer pulsatile SC kisspeptin for two weeks.
* During the course of kisspeptin administration, subjects will

  * Undergo q10 min blood sampling (approximately 4 sessions, 2 hours each)
  * Undergo pelvic ultrasounds (approximately 4 sessions)
* Optional q10 min sampling up to 10 hours may take place before and after the course of kisspeptin

Eligibility criteria: Inclusion Criteria:

* Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea)

  • Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins\]
* Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
* Laboratory Studies:

  * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women
  * Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration)
* Not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration
* No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration

Exclusion Criteria:

* Any condition (medical, mental, or behavioral) 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 active use of illicit drugs

  • Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. Individuals who regularly use marijuana may be asked to washout as referenced in the medication washout section below
* Pregnant or trying to become pregnant
* Breast feeding
* History of bilateral oophorectomy (ovaries were removed)

Primary outcomes:
measure: The proportion of participants that achieve development of a mature follicle or show evidence of ovulation
timeFrame: 2 weeks
Secondary outcomes:
measure: Change of luteinizing hormone (LH) pulse amplitude
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Stephanie Seminara, MD
role: PRINCIPAL_INVESTIGATOR
References: