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RECRUITING
NCT05896293
PHASE2

Kisspeptin Administration Subcutaneously to Patients With IHH

Sponsor: Stephanie B. Seminara, MD

View on ClinicalTrials.gov

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

Official title: Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-02-03

Completion Date

2028-05

Last Updated

2025-10-03

Healthy Volunteers

No

Interventions

DRUG

kisspeptin 112-121

SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)

DRUG

leuprolide acetate

Single SC bolus

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States