Pulsatile subcutaneous kisspeptin to trigger ovulation in women with hypothalamic amenorrhea
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
PHASE2 · Massachusetts General Hospital · NCT07224438
This trial tests whether two weeks of pulsed subcutaneous kisspeptin can trigger reproductive hormone release and stimulate ovarian follicle growth and egg release in women with hypothalamic amenorrhea.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07224438 on ClinicalTrials.gov |
What this trial studies
This is a single-arm Phase 2 study delivering kisspeptin 112-121 by a subcutaneous pump in a pulsatile fashion for two weeks to women with functional hypothalamic amenorrhea. Participants will have baseline screening including history, exam, labs, and a pelvic ultrasound, then receive continuous pulsatile dosing while undergoing repeated pelvic ultrasounds and frequent blood sampling to measure hormone responses. Blood samples will be taken every 10 minutes during several two-hour sessions (with optional extended sampling up to 10 hours before and after treatment), and ovarian follicle growth will be monitored with approximately four ultrasound visits. The protocol is designed to measure whether physiological patterns of gonadotropin release and follicular development can be restored by pulsatile kisspeptin delivery.
Who should consider this trial
Good fit: Women aged 18–45 with acquired functional hypothalamic amenorrhea (hypogonadotropic hypogonadism), who are medically stable, not currently using hormones that affect the reproductive axis (or are willing to complete a washout), and able to comply with frequent clinic visits are the intended candidates.
Not a fit: Patients with organic pituitary or hypothalamic disease, uncontrolled medical or psychiatric conditions, excessive alcohol use, inability to stop interfering medications, or who cannot attend frequent in-person monitoring are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this approach could restore ovulation and menstrual function and offer a nonstandard hormonal option to improve fertility in women with hypothalamic amenorrhea.
How similar studies have performed: Early-phase human studies have shown that kisspeptin can stimulate GnRH/gonadotropin release and has been used experimentally to provoke ovulation, but pulsatile subcutaneous delivery specifically to restore ovulation in hypothalamic amenorrhea remains relatively novel and is under active investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Ages 18-45 years * Acquired HH (hypothalamic amenorrhea, aka functional hypogonadotropic hypogonadism) * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg) * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women * Negative serum hCG pregnancy test * No current or recent use of a medication (including hormonal replacement) 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 its method of administration * If applicable, willing to use birth control methods (as approved by a study medical professional) during the entire study and for one month after the last dose of study drug 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) * Active use of illicit drugs * Pregnant * Trying to become pregnant during protocol participation * Breast feeding * History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Study Coordinator
- Email: MGHKisspeptinResearch@partners.org
- Phone: 617-643-2308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism, hypothalamic amenorrhea, hypogonadotropic hypogonadism, kisspeptin