Hyperandrogenemia and Altered Day-night LH Pulse Patterns

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT03068910
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

  • Micronized progesterone — DRUG
    Micronized progesterone 0.8 mg/kg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.
  • 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, androgen-receptor blockade (spironolactone) improves the ability of progesterone to acutely reduce waking luteinizing hormone pulse frequency (primary endpoint).

Key Dates

Start date
Jul 21, 2016
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 the 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

Luteinizing hormone (LH) pulse frequency [ Time Frame: During first CRU admission and during the second CRU admission (which occurs at least 2 months after the first) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Clinical Research UnitCharlottesvilleVirginia22908
Melissa Gilrain, BS
[email protected]
434-243-6911
Christine Burt Solorzano, M.D.
[email protected]
434-243-6911
Christine Burt Solorzano, M.D. (PRINCIPAL_INVESTIGATOR)
Christopher R McCartney, M.D. (SUB_INVESTIGATOR)

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University of Virginia Clinical Research Unit· Charlottesville, VA

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