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NCT07224438 · ClinicalTrials.gov registry record · Phase 2
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
A Phase 2 study of Hypogonadotropic Hypogonadism and Hypothalamic Amenorrhea, sponsored by Stephanie B. Seminara, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07224438: Recruiting Phase 2 study of Hypogonadotropic Hypogonadism and Hypothalamic Amenorrhea, sponsored by Stephanie B. Seminara, MD.
NCT07224438 is a Phase 2 study of Hypogonadotropic Hypogonadism and Hypothalamic Amenorrhea that is actively recruiting participants, run by Stephanie B. Seminara, MD. The registered enrollment target is 20 participants, below the 123-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07224438, a Phase 2 study of Hypogonadotropic Hypogonadism and Hypothalamic Amenorrhea, is actively recruiting participants, sponsored by Stephanie B. Seminara, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration
Conditions Studied
Interventions
- DRUG kisspeptin 112-121
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-12-09 |
| Est. Completion | 2030-05 |
| Phase | Phase 2 |
What NCT07224438 shows while recruiting
NCT07224438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 123-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Hypogonadotropic Hypogonadism appearing as the primary indexed condition, and to 1 intervention - of which kisspeptin 112-121 is the first listed.
NCT07224438 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07224438 about?
NCT07224438 is a clinical study titled "Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea". 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 ...
What is the current status of trial NCT07224438?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-12-09. Estimated completion is 2030-05.
What conditions does trial NCT07224438 study?
This clinical trial studies the following conditions: Hypogonadotropic Hypogonadism, Hypothalamic Amenorrhea.
What interventions are being tested in trial NCT07224438?
The interventions under investigation include: kisspeptin 112-121 (DRUG).
Who is sponsoring clinical trial NCT07224438?
This trial is sponsored by Stephanie B. Seminara, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07224438 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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