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NCT05896293 · ClinicalTrials.gov registry record · Phase 2
Kisspeptin Administration Subcutaneously to Patients With IHH
A Phase 2 study of Hypogonadotropic Hypogonadism, sponsored by Stephanie B. Seminara, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05896293: Recruiting Phase 2 study of Hypogonadotropic Hypogonadism, sponsored by Stephanie B. Seminara, MD.
NCT05896293 is a Phase 2 study of Hypogonadotropic Hypogonadism that is actively recruiting participants, run by Stephanie B. Seminara, MD. The registered enrollment target is 36 participants, below the 121-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05896293, a Phase 2 study of Hypogonadotropic Hypogonadism, is actively recruiting participants, sponsored by Stephanie B. Seminara, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 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 men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time. Funding Source: FDA OOPD
Primary Outcome
Average difference in LH amplitude after the first dose of kisspeptin (day 1) compared to the last dose of kisspeptin (day 15)
Conditions Studied
Interventions
- DRUG kisspeptin 112-121
- DRUG leuprolide acetate
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-02-03 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
What NCT05896293 shows while recruiting
NCT05896293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 121-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Hypogonadotropic Hypogonadism appearing as the primary indexed condition, and to 2 interventions - of which kisspeptin 112-121 is the first listed.
NCT05896293 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05896293 about?
NCT05896293 is a clinical study titled "Kisspeptin Administration Subcutaneously to Patients With IHH". The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from ...
What is the current status of trial NCT05896293?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2023-02-03. Estimated completion is 2028-05.
What conditions does trial NCT05896293 study?
This clinical trial studies the following conditions: Hypogonadotropic Hypogonadism.
What interventions are being tested in trial NCT05896293?
The interventions under investigation include: kisspeptin 112-121 (DRUG), leuprolide acetate (DRUG).
Who is sponsoring clinical trial NCT05896293?
This trial is sponsored by Stephanie B. Seminara, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05896293 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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