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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 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.

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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).

Interventions

  • DRUG Placebo
  • DRUG Spironolactone
  • DRUG Micronized progesterone

Study Locations (1)

Virginia

  • University of Virginia Clinical Research Unit - Charlottesville

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2016-07-21
Est. Completion 2025-12-01
Phase Early Phase 1

Sponsor

University of Virginia

449 total trials

What the Registry Record Tells You About NCT03068910

The ClinicalTrials.gov registry entry for NCT03068910 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 3 interventions - of which Placebo is the first listed.

NCT03068910 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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