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NCT03068910 · ClinicalTrials.gov registry record · Early Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
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
NCT03068910: Recruiting Early Phase 1 study of Polycystic Ovary Syndrome and Puberty, sponsored by University of Virginia.
NCT03068910 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
NCT03068910, 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, androgen-receptor blockade (spironolactone) improves the ability of progesterone to acutely reduce waking luteinizing hormone pulse frequency (primary endpoint).
Primary Outcome
LH pulse frequency while awake vs. while asleep
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Spironolactone
- DRUG Micronized progesterone
Study Locations (1)
Virginia
- University of Virginia Clinical Research Unit - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-07-21 |
| Est. Completion | 2025-12-01 |
| Phase | Early Phase 1 |
What NCT03068910 shows while recruiting
NCT03068910 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 3 interventions - of which Placebo is the first listed.
NCT03068910 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03068910 about?
NCT03068910 is a clinical study titled "Hyperandrogenemia and Altered Day-night LH Pulse Patterns". The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism, androgen-receptor blockade (spironolactone) improves the ability of progesterone to acutely reduce waking luteinizing hormone pulse frequency (primary endpoint).
What is the current status of trial NCT03068910?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2016-07-21. Estimated completion is 2025-12-01.
What conditions does trial NCT03068910 study?
This clinical trial studies the following conditions: Polycystic Ovary Syndrome, Puberty, Hyperandrogenism.
What interventions are being tested in trial NCT03068910?
The interventions under investigation include: Placebo (DRUG), Spironolactone (DRUG), Micronized progesterone (DRUG).
Who is sponsoring clinical trial NCT03068910?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03068910 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
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03068910'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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