Actively Recruiting
Study to Evaluate if Androgen-receptor Blockade (Spironolactone) Improves Progesterone-suppression of Wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism
Led by University of Virginia · Updated on 2025-08-05
32
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether blocking androgen receptors with spironolactone improves progesterone's ability to reduce waking luteinizing hormone (LH) pulse frequency in mid- to late pubertal girls with hyperandrogenism. This randomized, placebo-controlled, double-blinded crossover study focuses on girls who are candidates for spironolactone treatment. The study aims to understand hormonal changes related to hyperandrogenism during puberty. Participants will receive two weeks of pretreatment with either spironolactone (50 mg twice daily) or a placebo before each of two 18-hour Clinical Research Unit admissions, which occur in separate menstrual cycles at least two months apart. During admissions, oral micronized progesterone will be administered four times daily at specified times. Blood samples will be collected every 10 minutes overnight to assess LH pulse frequency and other hormone levels. Polysomnography will be done to monitor sleep during admissions. Girls will undergo detailed hormone monitoring during both admissions, with researchers measuring LH pulse frequency while awake as the primary outcome. Secondary measures include LH pulse frequency during sleep. The study includes assessments of hormone levels, sleep patterns, and safety monitoring. Participants will be closely observed throughout the study to evaluate the hormonal effects of spironolactone compared to placebo in response to progesterone. Total participation spans multiple menstrual cycles with careful crossover between treatments.
CONDITIONS
Brief Title
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mid- to late pubertal adolescent girl (at least Tanner breast stage 3, but no more than 2 years postmenarcheal)
- Hyperandrogenism defined by free testosterone above Tanner stage-specific range and/or clear evidence of hirsutism
- Generally good health except for overweight, obesity, hyperandrogenism, or well-treated hypothyroidism
- Able and willing to provide informed assent (under 16 years) or consent (16 years and older); parental or guardian consent for minors
- Willing to strictly avoid pregnancy using reliable non-hormonal methods during the study period
You will not qualify if you...
- Unable or incapable of providing informed consent
- Male gender
- Obesity caused by specific endocrine or genetic conditions
- Positive pregnancy test or currently breastfeeding
- Non-physiologic or non-PCOS causes of hyperandrogenism or anovulation
- Signs of virilization such as rapidly increasing hirsutism, deepening voice, or clitoromegaly
- Total testosterone over 150 ng/dl indicating possible tumor
- DHEA-S levels over 1.5 times upper normal limit (except mild elevations in HA or PCOS)
- Early morning 17-hydroxyprogesterone over 200 ng/dl in follicular phase (with confirmation and additional testing if elevated)
- Abnormal thyroid stimulating hormone unless stable and treated hypothyroidism
- Hyperprolactinemia more than 20% above normal limit (except mild elevations in HA/PCOS)
- History or signs of Cushing's syndrome, adrenal insufficiency, or acromegaly
- Signs of hypogonadotropic hypogonadism or functional hypothalamic amenorrhea
- Persistent low hematocrit or hemoglobin levels
- Severe low platelet or white blood cell counts
- Diabetes diagnosis or elevated fasting glucose or hemoglobin A1c
- Persistent liver abnormalities except mild elevations due to Gilbert's syndrome or obesity/HA/PCOS
- Significant heart or lung problems
- Reduced kidney function with GFR below 60 ml/min/1.73m2
- Personal history of breast, ovarian, or endometrial cancer
- Other cancer history unless disease free for 5 years
- Allergy to micronized progesterone or spironolactone
- BMI below 5th percentile for age (underweight)
- Body weight less than 25 kg due to blood draw volume
- Use of medications affecting reproductive, glucose, lipid metabolism, or blood pressure within 2 to 3 months prior to study start
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks for each pretreatment period
Participants receive two separate 2-week pretreatment periods with either spironolactone or placebo before clinical research unit admissions. The order of treatments is randomized and crossed over after at least 2 months.
Two 18-hour Clinical Research Unit admissions separated by at least 2 months
Trial Site Locations
Total: 1 location
1
University of Virginia Clinical Research Unit
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
M
Melissa Gilrain, MS
C
Christine Burt Solorzano, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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