Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

Phase 1

Completed

• Conditions: Hypogonadotropic Hypogonadism; Agonadism; Healthy Postmenopausal Women
• Interventions: Drug: kisspeptin 112-121; Drug: GnRH

• Registration Number: NCT01438073
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The investigators are looking for subjects to complete a study on the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the body to produce other reproductive hormones. However, giving someone a continued amount of kisspeptin over a period of time can have the opposite effect and tell the body to, for a short time, stop making hormones needed for reproduction. By giving 24-hour infusions of kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way bodies function normally and the role it has in conditions that affect the reproductive system.

Detailed Description

Please contact study staff for a detailed description.

Study Timeline

• Study First Submitted: 2011-08-24
• Study Start: 2011-09
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
kisspeptin, GnRH	kisspeptin 112-121	24-hour continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg), and single bolus of GnRH (gonadotropin-releasing hormone) (2.5-250 ng/kg)
kisspeptin, GnRH	GnRH	24-hour continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg), and single bolus of GnRH (gonadotropin-releasing hormone) (2.5-250 ng/kg)

Primary Outcome Measures

Name	Time	Method
Average difference in Luteinizing Hormone (LH) concentration at the beginning and end of kisspeptin infusion	24 hours

Secondary Outcome Measures

Name	Time	Method
Average difference in estradiol concentration at the beginning and end of kisspeptin infusion (females)	24 hours
Average difference in testosterone concentration at the beginning and end of kisspeptin infusion (males)	24 hours

Trial Locations

Locations (1)

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