Kisspeptin Administration in the Adult

Phase 1

Completed

• Conditions: Kallmann Syndrome; GnRH Deficiency; Polycystic Ovarian Syndrome; Hyperprolactinemia; Hypogonadotropic Hypogonadism; PCOS
• Interventions: Drug: kisspeptin 112-121; Drug: GnRH

• Registration Number: NCT00914823
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this study is to learn about the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that causes the release of other hormones, including gonadotropin-releasing hormone (GnRH) in the body.

Detailed Description

The reproductive hormone GnRH is essential for normal reproductive function. People with idiopathic hypogonadotropic hypogonadism (IHH), hyperprolactinemia, and polycystic ovarian syndrome (PCOS) do not secrete or respond to GnRH in a normal way. In this study, investigators will give participants kisspeptin-a hormone that is naturally found in the human body and is known to be a powerful stimulus of GnRH secretion. They may also give participants GnRH to determine if participants will be able to fully respond to kisspeptin. The goal of this study is to use kisspeptin administration to probe the condition of GnRH neurons in people with various reproductive disorders to better understand the underlying reasons for the disorders. Investigators hope to gain new insights into GnRH neuronal function (or dysfunction) that will lead to better diagnostics in the future.

Study Timeline

• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-04
• Study First Posted: 2009-06-05
• Study Start: 2009-06-23
• Primary Completion: 2021-10-22
• Study Completion: 2021-10-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
kisspeptin, GnRH	GnRH	Intravenous (IV) or subcutaneous (SC) administration of kisspeptin 112-121 and/or administration of GnRH
kisspeptin, GnRH	kisspeptin 112-121	Intravenous (IV) or subcutaneous (SC) administration of kisspeptin 112-121 and/or administration of GnRH

Primary Outcome Measures

Name	Time	Method
Average change in luteinizing hormone (LH) in response to kisspeptin	Within 30 minutes of administration

Trial Locations

Locations (1)

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