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Kisspeptin-10

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

Quick Stats
Studies 877
Trials 47
Recruiting PHASE2 INTERVENTIONAL NCT05896293

Kisspeptin Administration Subcutaneously to Patients With IHH

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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. 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

Detailed 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 single SC injection of leuprolide acetate may be administered approximately six days before kisspeptin administration. (Previously administration of Gonadotropin Releasing Hormone (GnRH) was used in this study.) * A pelvic ultrasound will be performed on women to assess baseline follicular size. * 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 4 sessions) * Optional q10 min sampling up to 8 hours may take place before and after the course of kisspeptin

Interventions

Name: kisspeptin 112-121
Type: DRUG
Description: SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)
Name: leuprolide acetate
Type: DRUG
Description: Single SC bolus

Primary Outcomes

Measure: Average change in luteinizing hormone (LH) pulse amplitude
TimeFrame: 2 weeks
Description: Average difference in LH amplitude after the first dose of kisspeptin (day 1) compared to the last dose of kisspeptin (day 15)

Trial Information

NCT ID

NCT05896293

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Stephanie B. Seminara, MD

Last Updated

December 15, 2025