NCT07224438

Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• 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 see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

Detailed description

Assignment: All study subjects will undergo the same interventions. Delivery of Interventions: * The subject will undergo a review of their medical history, physical exam, and screening laboratories. * A pelvic ultrasound will be performed to assess baseline follicular size. * A pump will be placed to administer pulsatile SC kisspeptin for two weeks. * During the course of kisspeptin administration, subjects will * Undergo q10 min blood sampling (approximately 4 sessions, 2 hours each) * Undergo pelvic ultrasounds (approximately 4 sessions) * Optional q10 min sampling up to 10 hours may take place before and after the course of kisspeptin

Conditions

• Hypothalamic Amenorrhea
• Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	kisspeptin 112-121	SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes)

Timeline

• Start date: 2025-12-09
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2025-11-04
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study