drugset / Trial / NCT07224438
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
Phase 2
Recruiting
20 enrolled
Massachusetts General Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-12-09
- Primary completion
- 2030-05
- Completion
- 2030-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | kisspeptin 112-121 | Peptide | — | Subcutaneous |