RecruitingEarly Phase 1NCT00929006

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

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


Sponsor

University of Virginia

Enrollment

36 participants

Start Date

Jun 1, 2008

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how the hormone progesterone affects LH pulses (signals from the brain that control the menstrual cycle) in teenage girls, specifically comparing effects during sleep versus waking hours — which may help explain why some girls with excess male hormones (hyperandrogenism) develop irregular periods. **You may be eligible if...** - You are a mid-to-late puberty adolescent girl (Tanner breast stage 3 or higher, no more than 2 years past first period) - You are in generally good health - You are willing to strictly avoid pregnancy using non-hormonal methods during the study - You may or may not have signs of high male hormones (hyperandrogenism/hirsutism) **You may NOT be eligible if...** - You are male - You are pregnant, currently breastfeeding, or have a positive pregnancy test - You have obesity from a known hormonal or genetic cause - You have signs of a serious hormone-producing tumor (very high testosterone, rapidly progressive symptoms) - You have diabetes, anemia, severe blood cell abnormalities, or serious heart/lung/kidney disease - You have a personal history of breast, ovarian, or endometrial cancer - You are underweight (BMI below the 5th percentile for your age) or weigh less than 25 kg - You have taken hormonal medications, metformin, steroids, or stimulants within the past 2–3 months - You have a history of allergy to micronized progesterone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMicronized progesterone suspension

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

DRUGPlacebo

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


Locations(1)

University of Virginia

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT00929006


Related Trials