RecruitingPhase 2NCT05896293

Kisspeptin Administration Subcutaneously to Patients With IHH

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders


Sponsor

Stephanie B. Seminara, MD

Enrollment

36 participants

Start Date

Feb 3, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called kisspeptin 112-121 and a drug called leuprolide acetate for people with hypogonadotropic hypogonadism. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGkisspeptin 112-121

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

DRUGleuprolide acetate

Single SC bolus


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT05896293


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