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NCT04723862 · ClinicalTrials.gov registry record · Early Phase 1
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
A Early Phase 1 study of Polycystic Ovary Syndrome and Puberty, sponsored by University of Virginia.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT04723862: Recruiting Early Phase 1 study of Polycystic Ovary Syndrome and Puberty, sponsored by University of Virginia.
NCT04723862 is a Early Phase 1 study of Polycystic Ovary Syndrome and Puberty that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 32 participants, below the 17,257-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04723862, a Early Phase 1 study of Polycystic Ovary Syndrome and Puberty, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism (HA), androgen-receptor blockade (spironolactone) alone normalizes sleep-wake luteinizing hormone (LH) pulse frequency (primary endpoint) and overall LH and follicle-stimulating hormone secretion (secondary endpoints).
Primary Outcome
The sleep-associated (22:00 h - 07:00 h) luteinizing hormone (LH) pulse frequency data from the spironolactone and placebo admissions will be analyzed via a hierarchical linear mixed model (HLMM). Sleep-associated LH pulse frequency will be compared between the spironolactone admission and the placebo admission via a linear contrast of the HLMM least squares LH pulse frequency means.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Spironolactone
Study Locations (1)
Virginia
- Center for Research in Reproduction, University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-11-12 |
| Est. Completion | 2025-12-01 |
| Phase | Early Phase 1 |
What NCT04723862 shows while recruiting
NCT04723862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 17,257-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Polycystic Ovary Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04723862 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04723862 about?
NCT04723862 is a clinical study titled "Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?". The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism (HA), androgen-receptor blockade (spironolactone) alone normalizes sleep-wake luteinizing hormone (LH) pulse frequency (primary endpoint) and overall LH and follicle-stimulating hormone secretion (seco...
What is the current status of trial NCT04723862?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2021-11-12. Estimated completion is 2025-12-01.
What conditions does trial NCT04723862 study?
This clinical trial studies the following conditions: Polycystic Ovary Syndrome, Puberty, Hyperandrogenism.
What interventions are being tested in trial NCT04723862?
The interventions under investigation include: Placebo (DRUG), Spironolactone (DRUG).
Who is sponsoring clinical trial NCT04723862?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04723862 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Polycystic Ovary Syndrome
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Where NCT04723862's enrollment target sits among peer trials
32 26th of 30 higher than 4 of 30 other Polycystic Ovary Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Polycystic Ovary Syndrome 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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