Kisspeptin treatment for patients with hypogonadotropic hypogonadism
Official title: Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Run by Massachusetts General Hospital · NCT05896293 · Data updated 2026-11-12
This study is testing if a hormone called kisspeptin can help people with low reproductive hormone levels due to hypogonadotropic hypogonadism by seeing how it affects hormone release and ovarian growth.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | February 3, 2023 |
| Main results expected | May 2028 |
| Study ends | May 2028 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT05896293 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with congenital idiopathic hypogonadotropic hypogonadism and who meet specific health criteria.
✕Probably not a fit
Patients with conditions that interfere with participation or those currently using hormonal replacement therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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 individuals with idiopathic hypogonadotropic hypogonadism (IHH). Participants will receive subcutaneous kisspeptin in a pulsatile manner for two weeks, with monitoring through blood sampling and ultrasound assessments. The study will assess both hormonal responses and ovarian follicular growth in women. All subjects will undergo a thorough medical evaluation prior to treatment.
Why it matters
Potential benefit: If successful, this treatment could restore reproductive hormone levels and improve fertility outcomes for patients with IHH.
How similar studies have gone: While the use of kisspeptin in this context is relatively novel, preliminary studies have shown promise in stimulating reproductive hormone release.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Congenital IHH * 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) * 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 * 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 (not including marijuana) * For women: * Pregnant or trying to become pregnant * Breast feeding * History of: bilateral oophorectomy (both ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding
Where it's running
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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
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Pulsatile subcutaneous kisspeptin to trigger ovulation in women with hypothalamic amenorrhea
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.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.