RecruitingEarly Phase 1NCT04723862

Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?

Does Spironolactone Normalize Sleep-wake Luteinizing Hormone (LH) Pulse Frequency in Pubertal Girls With Hyperandrogenism? (CBS010)


Sponsor

University of Virginia

Enrollment

32 participants

Start Date

Nov 12, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism (HA), androgen-receptor blockade (spironolactone) alone normalizes sleep-wake luteinizing hormone (LH) pulse frequency (primary endpoint) and overall LH and follicle-stimulating hormone secretion (secondary endpoints).


Eligibility

Sex: FEMALEMin Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether spironolactone — a medication that blocks male hormones — can normalize the way the brain releases a reproductive hormone (LH) during sleep in teenage girls who have high androgen (male hormone) levels. This hormonal imbalance is often an early sign of polycystic ovary syndrome (PCOS). **You may be eligible if:** - You are a girl between 10 and 17 years old in mid to late puberty - You have elevated levels of testosterone or signs of excess hair growth (hirsutism) - You are otherwise in good health - You are willing to use non-hormonal contraception during the study **You may NOT be eligible if:** - You are male - You are younger than 10 or older than 17 - You have been through menopause for more than 4 years - You are pregnant or breastfeeding - You weigh less than 21.5 kg - You have diabetes, significant liver or kidney problems, high potassium, adrenal disease, or a history of cancer - You have signs of another cause for high androgen levels (not PCOS-related) 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

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)

Center for Research in Reproduction, University of Virginia

Charlottesville, Virginia, United States

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NCT04723862


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