drugset / Trial / NCT05896293

Kisspeptin Administration Subcutaneously to Patients With IHH

NCT05896293

Phase 2 Recruiting 36 enrolled Massachusetts General Hospital
NaSingle-groupOpen-labelOther

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

Timeline

Start
2023-02-03
Primary completion
2028-05
Completion
2028-05

Drugs

EvaluationDrugModalityDoseRoute
Subject kisspeptin 112-121 Peptide Subcutaneous
Background Leuprolide Other / unclassified Subcutaneous