NCT01952782

Neuropeptides in Human Reproduction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone. We hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.

Conditions

• Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	Kisspeptin 112-121	Subjects will receive up to 10 IV doses of kisspeptin 112-121
DRUG	Naloxone	Subjects will receive one IV dose of naloxone followed by an IV infusion of naloxone.
DRUG	GnRH	Subjects will receive up to 10 doses of IV GnRH

Timeline

• Start date: 2014-04-30
• Primary completion: 2016-05-31
• Completion: 2016-05-31
• First posted: 2013-09-30
• Last updated: 2024-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study