RecruitingHyperandrogenismPolycystic Ovary SyndromePuberty
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
Eligible age
10–17 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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).
Sponsor: University of Virginia
You may qualify if…
- ✓ Mid- to late pubertal adolescent girls as signified by either (a) post-menarcheal status (Tanner breast stages 2-5) or (b) Tanner breast stage of 4 or 5 (whether pre-menarcheal or post-menarcheal) ages 10-17 years.
- ✓ Hyperandrogenism, defined as a serum (calculated) free testosterone concentration greater than the Tanner stage-specific reference range and/or clinical hirsutism
- ✓ General good health (excepting obesity, hyperandrogenism, PCOS, and adequately-treated hypothyroidism)
- ✓ Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period.
You may not qualify if…
- ✕ Inability/incapacity to provide informed consent
- ✕ Males will be excluded (hyperandrogenism is unique to females)
- ✕ Age \< 10 or \> 17 years (this study is designed to elucidate mechanisms underlying emerging PCOS in mid- to late pubertal adolescent girls
- ✕ Post-menarcheal by \> 4 years
- ✕ Obesity resulting from a well-defined endocrinopathy, or genetic syndrome
- ✕ To ensure that blood withdrawal is within safe limits, weight \< 21.5 kg is an exclusion criterion.
- ✕ Since underweight can alter pulsatile LH secretion, BMI-for-age percentile \< 5 is an exclusion criterion.
- ✕ Positive pregnancy test or current lactation. Subjects with a positive pregnancy test will be informed of the result by the screening physician. Under Virginia law, parental notification is not required for minors. However, the screening physician will encourage the subject to tell her parent(s). We will counsel the adolescent about the importance of appropriate prenatal care/counseling. We will offer appropriate follow-up at the Teen Health Clinic at UVA and/or encourage the adolescent to secure prompt care via their primary care physician's office.
Where it's recruiting
Virginia
Charlottesville
Source: ClinicalTrials.gov · NCT04723862 · last updated 2025-08-05