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Hyperandrogenemia and Altered Day-night LH Pulse Patterns

NCT03068910 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-08-05

No results posted yet for this 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).

Conditions

  • Hyperandrogenism
  • Polycystic Ovary Syndrome
  • Puberty

Interventions

DRUG

Micronized progesterone

Micronized progesterone 0.8 mg/kg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.

DRUG

Spironolactone

Spironolactone is an androgen-receptor blocker commonly used (off-label) for hyperandrogenism. The spironolactone dose will be 50 mg taken orally twice daily (for two weeks before admission to the Clinical Research Unit).

DRUG

Placebo

Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Christine Burt Solorzano, M.D. · University of Virginia Center for Research in Reproduction

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-21
Primary Completion
2025-10-01
Completion
2025-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03068910 on ClinicalTrials.gov