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NCT05633966 · ClinicalTrials.gov registry record · Phase 1
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
A Phase 1 study, sponsored by Stephanie B. Seminara, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT05633966: Completed Phase 1 study, sponsored by Stephanie B. Seminara, MD.
NCT05633966 is a Phase 1 study that has completed, run by Stephanie B. Seminara, MD. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05633966, a Phase 1 study, has completed, sponsored by Stephanie B. Seminara, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
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
Mature follicle achievement is defined as evidence of a follicle with maximum diameter ≥18 mm. Evidence of ovulation is defined as detection of a corpus luteum on ultrasound in combination with elevated progesterone level.
Interventions
- DRUG Kisspeptin 112-121
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2022-12-16 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 1 |
What the finished NCT05633966 record still lists
NCT05633966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Kisspeptin 112-121 is the first listed.
NCT05633966 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05633966 about?
NCT05633966 is a clinical study titled "Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders". 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 NCT05633966?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2022-12-16. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT05633966?
The interventions under investigation include: Kisspeptin 112-121 (DRUG).
Who is sponsoring clinical trial NCT05633966?
This trial is sponsored by Stephanie B. Seminara, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05633966's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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