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Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism

NCT00929006 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-08-05

No results posted yet for this study

Summary

The purpose of this study is two-fold. (1) We will determine if in mid- to late pubertal girls without hyperandrogenism (HA), progesterone (P4) acutely reduces waking luteinizing hormone (LH) frequency to a greater extent than sleep-associated LH frequency. (2) We will determine if in mid- to late pubertal girls with HA, P4 will acutely suppress waking LH frequency to a lesser degree than it does in girls without HA.

Conditions

  • Puberty
  • Hyperandrogenism

Interventions

DRUG

Micronized progesterone suspension

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

DRUG

Placebo

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Christine M Burt Solorzano, MD · University of Virginia

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
2008-06-30
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 NCT00929006 on ClinicalTrials.gov