Clinical Trial

Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

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 women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-11-03; most recent amendment 2026-07-09.
Trial Details
NCT Number NCT07224438
Lead Sponsor Stephanie B. Seminara, MD
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism
Enrollment 20 participants
Start Date 2025-12-09
Primary Completion 2030-05 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-13