Actively Recruiting
Does Spironolactone Normalize Sleep-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
211 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
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).
CONDITIONS
Official 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, defined by post-menarcheal status (Tanner breast stages 2-5) or Tanner breast stage 4 or 5 (pre- or post-menarcheal)
- Hyperandrogenism, shown by high serum free testosterone or clinical hirsutism
- Generally good health except for obesity, hyperandrogenism, PCOS, or well-treated hypothyroidism
- Willingness to strictly 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 sex
- Age under 10 or over 17 years
- More than 4 years post-menarche
- Obesity caused by endocrine disorders or genetic syndromes
- Weight under 21.5 kg
- Body mass index (BMI) below 5th percentile for age
- Positive pregnancy test or currently breastfeeding
- Non-PCOS causes of hyperandrogenism or anovulation
- Signs of virilization such as rapid hirsutism, voice deepening, or clitoromegaly
- Total testosterone over 150 ng/dl
- DHEA-S more than 1.5 times the upper normal limit (except mild elevations in PCOS/HA)
- Early morning 17-hydroxyprogesterone over 300 ng/dl in follicular phase (confirmed on repeat)
- Abnormal thyroid-stimulating hormone (TSH) levels not stable for 6 months or untreated hypothyroidism
- Prolactin levels over 30 ng/mL (confirmed on repeat)
- Signs or history of Cushing's syndrome, adrenal insufficiency, or acromegaly
- Signs or history of hypogonadotropic hypogonadism or functional hypothalamic amenorrhea
- Persistent low hemoglobin below 11.5 g/dL (non-African American) or 11.0 g/dL (African American)
- Severe low platelet or white blood cell counts
- Diabetes diagnosis or high fasting glucose or HbA1c
- Persistent abnormal sodium, potassium, or bicarbonate levels
- Liver test abnormalities except mild stable elevations related to known conditions
- Allergy to spironolactone or contraindications such as kidney failure, hyperkalemia, or use of eplerenone
- Significant heart or lung problems
- Reduced kidney function with GFR below 60 ml/min/1.73m2
- History of cancer except skin basal or squamous cell carcinoma unless disease-free for 5 years
AI-Screening
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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
CONTACT
C
Christine Burt Solorzano, MD
CONTACT
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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