RecruitingEarly Phase 1NCT03068910

Hyperandrogenemia and Altered Day-night LH Pulse Patterns

Study to Evaluate if Androgen-receptor Blockade (Spironolactone) Improves Progesterone-suppression of Wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism


Sponsor

University of Virginia

Enrollment

32 participants

Start Date

Jul 21, 2016

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether excess male hormones (androgens) in teenage girls disrupt the normal 24-hour rhythm of a key reproductive hormone (LH — luteinizing hormone), which could help explain why some girls develop irregular periods and hormonal imbalances leading to Polycystic Ovary Syndrome (PCOS). **You may be eligible if...** - You are a mid-to-late pubescent adolescent girl (at least Tanner breast stage 3, but no more than 2 years past your first period) - You have elevated male hormone levels or clear signs of excess body/facial hair (hirsutism) - You are in generally good health - You are willing to avoid pregnancy using reliable non-hormonal methods during the study **You may NOT be eligible if...** - You are male - You have a known hormonal condition (other than PCOS) causing your symptoms, such as adrenal or ovarian tumors, or congenital adrenal hyperplasia - You have diabetes or significantly abnormal blood sugar - You are pregnant or currently breastfeeding - You have a significant heart, lung, or kidney condition - You have a personal history of breast, ovarian, or uterine cancer - You have taken hormonal medications, diabetes drugs, or blood pressure medications within the past 2–3 months - Your body weight is below the 5th percentile for your age (underweight) or under 25 kg 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.

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Interventions

DRUGMicronized progesterone

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

DRUGSpironolactone

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).

DRUGPlacebo

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


Locations(1)

University of Virginia Clinical Research Unit

Charlottesville, Virginia, United States

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NCT03068910


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