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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04723862
The ClinicalTrials.gov registry entry for NCT04723862 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 17,257-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (100% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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