Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls Wi… (NCT04723862) | Clinical Trial Compass
RecruitingEarly Phase 1
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
United States32 participantsStarted 2021-11-12
Plain-language summary
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).
Who can participate
Age range10 Years – 17 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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…
What they're measuring
1
Change in Sleep-Associated Luteinizing Hormone (LH) Pulse Frequency Between Admission With Spironolactone Versus Placebo