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RECRUITING Early Phase 1

Hyperandrogenemia and Altered Day-night LH Pulse Patterns

NCT03068910 · View on ClinicalTrials.gov ↗

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

392 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03068910

The ClinicalTrials.gov registry entry for NCT03068910 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 392 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03068910 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03068910?

The interventions under investigation include: Placebo (DRUG), Spironolactone (DRUG), Micronized progesterone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03068910?

This trial is sponsored by University of Virginia, which has 392 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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