NCT04648969

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Stephanie B. Seminara, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.

Detailed description

* Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure. * Delivery of Interventions: * Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit. * On the day of the inpatient study, the subjects will * Undergo q10 min blood sampling for 6 hours, * Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total), * Undergo q10 min blood samplings for another 6 hours, * Receive a single GnRH IV bolus at hour 51.

Conditions

• Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	kisspeptin 112-121	20 intravenous doses of kisspeptin 112-121 (4 different doses of kisspeptin (randomized) in 5 sets)
DRUG	GnRH	1 intravenous dose of GnRH

Timeline

• Start date: 2019-05-03
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2020-12-02
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study