Kisspeptin treatment for patients with hypogonadotropic hypogonadism
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
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 |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05896293 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 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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with congenital idiopathic hypogonadotropic hypogonadism and who meet specific health criteria.
Not a fit: Patients with conditions that interfere with participation or those currently using hormonal replacement therapy may not benefit from this study.
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 performed: While the use of kisspeptin in this context is relatively novel, preliminary studies have shown promise in stimulating reproductive hormone release.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Congenital IHH o 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 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 o Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. * 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 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.