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NCT04975334 · ClinicalTrials.gov registry record · Phase 1
Opioid Antagonism in Hypogonadotropic Hypogonadism
A Phase 1 study of Hypogonadotropic Hypogonadism and Low Testosterone, sponsored by Stephanie B. Seminara, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT04975334: Completed Phase 1 study of Hypogonadotropic Hypogonadism and Low Testosterone, sponsored by Stephanie B. Seminara, MD.
NCT04975334 is a Phase 1 study of Hypogonadotropic Hypogonadism and Low Testosterone that has completed, run by Stephanie B. Seminara, MD. The registered enrollment target is 23 participants, below the 123-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04975334, a Phase 1 study of Hypogonadotropic Hypogonadism and Low Testosterone, has completed, sponsored by Stephanie B. Seminara, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH).
Primary Outcome
Change in mean LH before vs. after naloxone bolus
Conditions Studied
Interventions
- DRUG Naloxone
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2025-06-18 |
| Est. Completion | 2025-09-26 |
| Phase | Phase 1 |
What the finished NCT04975334 record still lists
NCT04975334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 123-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Hypogonadotropic Hypogonadism appearing as the primary indexed condition, and to 1 intervention - of which Naloxone is the first listed.
NCT04975334 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04975334 about?
NCT04975334 is a clinical study titled "Opioid Antagonism in Hypogonadotropic Hypogonadism". The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH).
What is the current status of trial NCT04975334?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2025-06-18. Estimated completion is 2025-09-26.
What conditions does trial NCT04975334 study?
This clinical trial studies the following conditions: Hypogonadotropic Hypogonadism, Low Testosterone.
What interventions are being tested in trial NCT04975334?
The interventions under investigation include: Naloxone (DRUG).
Who is sponsoring clinical trial NCT04975334?
This trial is sponsored by Stephanie B. Seminara, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04975334 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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