Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Phase 2

Recruiting

• Conditions: Hypogonadotropic Hypogonadism
• Interventions: Drug: kisspeptin 112-121; Drug: GnRH

• Registration Number: NCT04648969
• Lead Sponsor: Stephanie B. Seminara, MD

Brief 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.

Study Timeline

• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Study Start: 2021-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: kisspeptin, GnRH	GnRH	• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
Experimental: kisspeptin, GnRH	kisspeptin 112-121	• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.

Primary Outcome Measures

Name	Time	Method
Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin	52 hours	Change in LH amplitude before, during and after kisspeptin administration

Secondary Outcome Measures

Name	Time	Method
Average change in LH pulse frequency in response to kisspeptin	52 hours	Change in LH frequency before and after kisspeptin administration

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States