NCT02956447

Administration of Kisspeptin in Patients With Hyperprolactinemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperprolactinemia
• Hypogonadism

Interventions

Type	Name	Description
DRUG	Kisspeptin 112-121	0.313 ug/kg - 2 ug/kg IV or SC
DRUG	GnRH	0.075 ug/kg IV

Timeline

• Start date: 2017-11-17
• Primary completion: 2023-06-28
• Completion: 2023-07-29
• First posted: 2016-11-07
• Last updated: 2024-10-01
• Results posted: 2024-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study