NCT01438073

Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypogonadotropic Hypogonadism
• Healthy Postmenopausal Women
• Agonadism

Interventions

Type	Name	Description
DRUG	kisspeptin 112-121	24-h 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)
DRUG	GnRH	Single intravenous dose of GnRH (2.5-250 ng/kg)

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2011-09-21
• Last updated: 2022-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study