Study of Subcutaneous Kisspeptin Hormone Treatment for Adults With Idiopathic Hypogonadotropic Hypogonadism Phase 2 Clinical Trial Evaluating Hormone Stimulation and Ovarian Response

What this Trial Is About

This research aims to evaluate whether kisspeptin, a natural hormone, can stimulate the release of reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism IHH. The study also explores if kisspeptin can help women release eggs from their ovaries. The trial is a phase 2 interventional study funded by the FDA Office of Orphan Products Development. Participants receive subcutaneous SC administration of kisspeptin via a pump in a pulsatile manner every 60 to 240 minutes for two weeks. Some participants may receive a single SC injection of leuprolide acetate about six days before starting kisspeptin. Women will have pelvic ultrasounds to monitor ovarian follicle growth, while frequent blood samples will be collected every 10 minutes for up to 70 minutes to observe hormone responses. Optional extended blood sampling may also occur before and after kisspeptin treatment. Throughout the study, participants undergo medical history reviews, physical exams, and laboratory screenings. Women have pelvic ultrasounds approximately four times during treatment. Blood sampling sessions occur frequently to measure hormone levels and assess the physiological response to kisspeptin. The primary outcome is the average change in luteinizing hormone LH pulse amplitude over two weeks, with secondary outcomes including the percentage of women showing mature follicles or ovulation. The total study duration extends to May 2028, with ongoing monitoring and assessments.

Kisspeptin Administration Subcutaneously to Patients With IHH