Actively Recruiting
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
Led by University of Virginia · Updated on 2025-08-05
32
Participants Needed
1
Research Sites
488 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, androgen-receptor blockade (spironolactone) improves the ability of progesterone to acutely reduce waking luteinizing hormone pulse frequency (primary endpoint).
CONDITIONS
Official 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 reference range and/or clear evidence of excess hair growth (hirsutism)
- Generally good health except for overweight, obesity, hyperandrogenism, or treated hypothyroidism
- Able and willing to give informed assent or consent (adolescents under 16 assent; those over 16 consent; parents/guardians consent for all)
- 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 due to known endocrine or genetic disorders
- Positive pregnancy test or currently breastfeeding
- Non-physiologic or non-PCOS causes of hyperandrogenism or anovulation
- Signs of virilization such as rapidly progressing hair growth, deepening voice, or enlarged clitoris
- Total testosterone over 150 ng/dl suggesting possible tumors
- DHEA-S levels more than 1.5 times upper normal limit (mild elevations allowed in HA or PCOS)
- Early morning 17-hydroxyprogesterone over 200 ng/dl in follicular phase (with repeat testing and possible stimulation test if confirmed)
- Abnormal thyroid stimulating hormone unless stable and treated hypothyroidism
- Prolactin levels more than 20% above normal (mild elevations accepted in HA/PCOS)
- History or signs of Cushing's syndrome, adrenal insufficiency, or acromegaly
- History or signs of hypogonadotropic hypogonadism including functional hypothalamic amenorrhea
- Persistent low hematocrit (<36%) or hemoglobin (<12 g/dl)
- Severe low platelets (<50,000) or low white blood count (<4,000)
- Diabetes diagnosis or high fasting glucose (≥126 mg/dl) or hemoglobin A1c (≥6.5%)
- Persistent liver abnormalities except mild bilirubin elevation from Gilbert's syndrome or mild transaminase elevations (<1.5x normal)
- Significant heart or lung problems such as heart failure or asthma requiring steroids
- Reduced kidney function with GFR < 60 ml/min/1.73m2
- Personal history of breast, ovarian, or endometrial cancer
- Other cancers unless disease-free for 5 years, excluding some skin cancers
- Allergy to micronized progesterone or spironolactone
- Body mass index below the 5th percentile for age (underweight)
- Body weight less than 25 kg due to blood draw limits
- Use of medications affecting reproductive system, glucose, lipids, or blood pressure within 2-3 months prior to study start
AI-Screening
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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
CONTACT
C
Christine Burt Solorzano, M.D.
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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