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Kisspeptin-10

KP-10, Metastin (45-54), Kisspeptin-10 (human), KiSS-1

Quick Stats
Studies 877
Trials 47
Completed PHASE2 INTERVENTIONAL NCT04648969

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

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

Primary Outcomes

Measure: Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin
TimeFrame: 52 hours
Description: Change in LH amplitude before, during and after kisspeptin administration

Trial Information

NCT ID

NCT04648969

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Stephanie B. Seminara, MD

Last Updated

December 15, 2025