Completed
PHASE1
INTERVENTIONAL
NCT01952782
Neuropeptides in Human Reproduction
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Kisspeptin 112-121
Type:
DRUG
Description:
Subjects will receive up to 10 IV doses of kisspeptin 112-121
Name:
Naloxone
Type:
DRUG
Description:
Subjects will receive one IV dose of naloxone followed by an IV infusion of naloxone.
Name:
GnRH
Type:
DRUG
Description:
Subjects will receive up to 10 doses of IV GnRH
Primary Outcomes
Measure:
Average difference in luteinizing hormone (LH) concentration before and after kisspeptin
TimeFrame:
Within 30 minutes of administration
Description:
Compares response to kisspeptin on and off naloxone infusion
Trial Information
NCT ID
NCT01952782
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Massachusetts General Hospital
Last Updated
December 15, 2025