Actively Recruiting
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone (LH) Pulse Frequency in Pubertal Girls With Hyperandrogenism? (CBS010)
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 spironolactone, an androgen-receptor blocker, can normalize sleep-wake luteinizing hormone (LH) pulse frequency in mid- to late pubertal girls with hyperandrogenism. The study focuses on adolescent girls aged 10 to 17 who have elevated free testosterone levels or clinical signs of excess androgens. This early phase 1 trial aims to understand how spironolactone affects hormone secretion patterns during sleep and wakefulness in this group. The study uses a randomized, placebo-controlled, double-blinded crossover design. Participants receive either spironolactone 50 mg twice daily or a placebo for two weeks before each of two clinical research unit admissions, spaced at least four weeks apart. During admissions, blood samples are taken every 10 minutes from late afternoon to early morning to measure pulsatile LH secretion, and polysomnography is performed to monitor sleep stages. Participants switch treatments between admissions to compare effects. During the study, participants will undergo close monitoring including frequent blood draws and sleep studies. Researchers will measure changes in sleep-associated and wake-associated LH pulse frequencies and analyze how REM sleep influences LH pulse initiation with and without spironolactone. The primary outcome is the change in sleep-associated LH pulse frequency over about two months. Safety and hormone levels will be carefully observed throughout the trial period.
CONDITIONS
Brief Title
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mid- to late pubertal adolescent girls aged 10 to 17 years
- Post-menarcheal status with Tanner breast stages 2-5, or Tanner breast stage 4 or 5 if pre- or post-menarcheal
- Hyperandrogenism defined by elevated free testosterone or clinical hirsutism
- General good health except obesity, hyperandrogenism, PCOS, and well-treated hypothyroidism
- Willingness to avoid pregnancy using reliable non-hormonal methods during the study period
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Male gender
- Age younger than 10 or older than 17 years
- More than 4 years post-menarche
- Obesity due to known endocrinopathy or genetic syndrome
- Weight less than 21.5 kg
- BMI-for-age percentile below 5
- Positive pregnancy test or current lactation
- Non-PCOS causes of hyperandrogenism or anovulation
- Signs of virilization or very high testosterone levels (>150 ng/dl)
- DHEA-S levels more than 1.5 times upper limit (except mild elevations)
- Elevated 17-hydroxyprogesterone suggesting congenital adrenal hyperplasia
- Abnormal or unstable thyroid function tests outside accepted ranges
- Prolactin levels above 30 ng/mL
- Signs of Cushing's syndrome, adrenal insufficiency, or acromegaly
- Symptoms of hypogonadotropic hypogonadism or functional hypothalamic amenorrhea
- Low hemoglobin below specified thresholds
- Severe thrombocytopenia or leukopenia
- Diabetes diagnosis or high fasting glucose/HbA1c
- Abnormal sodium, potassium, or bicarbonate levels
- Liver test abnormalities except stable mild elevations or Gilbert's syndrome
- Allergy or medical contraindications to spironolactone
- Significant heart or lung disease
- Decreased kidney function with GFR less than 60 ml/min/1.73m2
- History of cancer except certain skin cancers without recent disease
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 per treatment period, with at least 4 weeks between periods
Participants take spironolactone or placebo twice daily for 2 weeks before each clinical research unit admission. This is followed by detailed overnight assessments including blood sampling and polysomnography.
2 clinical research unit admissions with overnight stays, separated by at least 4 weeks
Trial Site Locations
Total: 1 location
1
Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
M
Melissa Gilrain, BS
C
Christine Burt Solorzano, MD
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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