Clinical Trial

Kisspeptin Administration Subcutaneously to Patients With IHH

Recruiting Phase 2
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Summary
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time. Funding Source: FDA OOPD
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-05-31; most recent amendment 2026-07-09.
Trial Details
NCT Number NCT05896293
Lead Sponsor Stephanie B. Seminara, MD
Conditions Hypogonadotropic Hypogonadism
Enrollment 36 participants
Start Date 2023-02-03
Primary Completion 2028-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-13