NCT05971849

Dampening the Reproductive Axis With Continuous Kisspeptin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Stephanie B. Seminara, MD · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).

Detailed description

Assignment: All study subjects will undergo the same interventions. Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion. Delivery of Interventions: * Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories. * On the day of the study, the subjects will have an intravenous (IV) line placed and * Undergo up to q10 min blood sampling x 36 hours * Receive an infusion of kisspeptin x 24 hours * Receive up to two kisspeptin IV boluses

Conditions

• Reproductive Disorder
• PCOS
• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	kisspeptin 112-121	IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin

Timeline

• Start date: 2023-10-06
• Primary completion: 2024-04-27
• Completion: 2024-04-27
• First posted: 2023-08-02
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study