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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT04723862
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Hyperandrogenism
  • Polycystic Ovary Syndrome
  • Puberty

Eligibility Criteria

Sex
FEMALE
Age
10 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Spironolactone — DRUG
    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).
  • Placebo — DRUG
    Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.

Study Details

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).

Key Dates

Start date
Nov 12, 2021
Status verified
Jul 2025
Primary completion
Oct 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Spironolactone
    Prior to the first or second admission (randomly determined), participants will be pretreated for 2 weeks with spironolactone (50 mg twice daily).
  • Placebo Comparator: Placebo
    Prior to the first or the second admission (randomly determined), participants will be pretreated for 2 weeks with placebo (twice daily).

Primary Outcome Measure

Change in Sleep-Associated Luteinizing Hormone (LH) Pulse Frequency Between Admission With Spironolactone Versus Placebo [ Time Frame: Baseline to 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Research in Reproduction, University of VirginiaCharlottesvilleVirginia22908
Melissa Gilrain, BS
[email protected]
434-243-6911
Christine M Burt Solorzano, MD
[email protected]
434-924-9084
Christine M Burt Solorzano, MD (PRINCIPAL_INVESTIGATOR)
Christopher R McCartney, MD (SUB_INVESTIGATOR)

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By research site
Center for Research in Reproduction, University of Virginia· Charlottesville, VA

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