Kisspeptin Administration Subcutaneously to Patients With IHH

Status Recruiting

Clinical Trial 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. Gonadotropin-releasing hormone (GnRH) may be administered subcutaneously (SC) for approximately six days in a pulsatile fashion, in order to prime the pituitary gland. 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

Clinical Trial Description

Assignment: All study subjects will undergo the same interventions. Delivery of Interventions: - Each subject will undergo a review of their medical history, physical exam, and screening laboratories. - A pelvic ultrasound will be performed on women to assess baseline follicular size. - A pump may be placed to administer pulsatile SC GnRH for approximately six days. - A pump will be placed to administer pulsatile SC kisspeptin for two weeks. - During the course of kisspeptin administration, subjects will - Undergo q10 min blood sampling (approximately 10 sessions, 70 minutes each) - For women, undergo pelvic ultrasounds (approximately 3 sessions) - Optional q10 min sampling up to 8 hours may take place before and after the course of kisspeptin ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05896293
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Study Coordinator
Phone	617-724-8592
Email	MGHKisspeptinResearch@partners.org
Status	Recruiting
Phase	Phase 2
Start date	February 3, 2023
Completion date	June 30, 2027

View Details

See also
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