Kisspeptin treatment for women with reproductive disorders
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
This study is testing if a hormone called kisspeptin can help women with certain reproductive disorders release eggs and improve their hormone levels.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05633966 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of kisspeptin, a naturally occurring hormone, on stimulating the release of reproductive hormones in women diagnosed with hypothalamic amenorrhea and hypogonadotropic hypogonadism. Participants will receive subcutaneous kisspeptin administration in a pulsatile manner over two weeks, with close monitoring through ultrasound and frequent blood sampling to assess ovarian response. The study will help determine if kisspeptin can facilitate egg release from the ovaries and improve reproductive hormone levels.
Who should consider this trial
Good fit: Ideal candidates include women diagnosed with acquired hypogonadotropic hypogonadism, specifically those with hypothalamic amenorrhea.
Not a fit: Patients currently using hormonal replacement therapy or those with conditions that affect the reproductive axis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could restore reproductive hormone levels and ovarian function in women with specific reproductive disorders.
How similar studies have performed: While the use of kisspeptin in reproductive disorders is a novel approach, preliminary studies have shown promise in stimulating reproductive hormone release.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Seminara, MD — Massachusetts General Hospital
- Study coordinator: Study Coordinator
- Email: MGHKisspeptinResearch@partners.org
- Phone: 617-726-1895
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.