Subcutaneous Kisspeptin Treatment for Women Aged 18 to 45 with Hypothalamic Amenorrhea to Stimulate Reproductive Hormones

What this Trial Is About

Researchers are evaluating whether kisspeptin, a natural hormone, can stimulate the release of reproductive hormones and help egg release in women with hypothalamic amenorrhea HA, a form of acquired hypogonadotropic hypogonadism. This Phase 2 study focuses on women aged 18 to 45 with normal blood pressure and no interfering conditions. The purpose is to understand kisspeptins effects on hormone release and ovarian function. Participants will receive kisspeptin through a pump that delivers the hormone subcutaneously in a pulsatile manner approximately every 90 minutes for two weeks. During this treatment, participants will have frequent blood samples taken every 10 minutes for up to two hours across about four sessions, as well as pelvic ultrasounds to monitor ovarian follicle growth. Optional extended blood sampling sessions lasting up to 10 hours may occur before and after the kisspeptin treatment. Throughout the study, participants will undergo medical history reviews, physical exams, and lab screenings, including pregnancy tests and baseline pelvic ultrasounds. The primary outcome measured is the change in luteinizing hormone LH pulse amplitude after two weeks of treatment. Safety and physiologic responses will be monitored by frequent blood collections and ultrasound evaluations. The total participation period spans the kisspeptin administration and associated assessments, concluding by May 2030.

Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea