Who is sponsoring NCT07224438?

NCT07224438 is sponsored by Stephanie B. Seminara, MD.

What condition does NCT07224438 study?

NCT07224438 studies Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism.

What drugs are being tested in NCT07224438?

Interventions: kisspeptin 112-121.

What is the status of NCT07224438?

NCT07224438 is currently RECRUITING.

Last reviewed 2025-12-29 · How we verify

Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

NCT07224438 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 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.

Details

Lead sponsor	Stephanie B. Seminara, MD
Phase	Phase 2
Status	RECRUITING
Enrolment	20
Start date	2025-12-09
Completion	2030-05

Conditions

Hypothalamic Amenorrhea
Hypogonadotropic Hypogonadism

Interventions

kisspeptin 112-121

Primary outcomes

Change of luteinizing hormone (LH) pulse amplitude — 2 weeks
Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration

Countries

United States