Who is sponsoring NCT05896293?

NCT05896293 is sponsored by Stephanie B. Seminara, MD.

What condition does NCT05896293 study?

NCT05896293 studies Hypogonadotropic Hypogonadism.

What drugs are being tested in NCT05896293?

Interventions: kisspeptin 112-121, leuprolide acetate.

What is the status of NCT05896293?

NCT05896293 is currently RECRUITING.

Last reviewed 2025-09-30 · How we verify

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

NCT05896293 Phase 2 RECRUITING

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

Details

Lead sponsor	Stephanie B. Seminara, MD
Phase	Phase 2
Status	RECRUITING
Enrolment	36
Start date	2023-02-03
Completion	2028-05

Conditions

Hypogonadotropic Hypogonadism

Interventions

kisspeptin 112-121
leuprolide acetate

Primary outcomes

Average change in luteinizing hormone (LH) pulse amplitude — 2 weeks
Average difference in LH amplitude after the first dose of kisspeptin (day 1) compared to the last dose of kisspeptin (day 15)

Countries

United States