Completed
PHASE2
INTERVENTIONAL
NCT02956447
Administration of Kisspeptin in Patients With Hyperprolactinemia
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (IV) kisspeptin administration). Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.
Interventions
Name:
Kisspeptin 112-121
Type:
DRUG
Description:
0.313 ug/kg - 2 ug/kg IV or SC
Name:
GnRH
Type:
DRUG
Description:
0.075 ug/kg IV
Primary Outcomes
Measure:
Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours
TimeFrame:
Up to 14 days
Description:
Average change in LH pulse frequency at baseline and during kisspeptin IV administration
Measure:
Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin
TimeFrame:
Evaluated over eight days
Description:
Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration
Trial Information
NCT ID
NCT02956447
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Massachusetts General Hospital
Last Updated
December 15, 2025