Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Andr… (NCT04075149) | Clinical Trial Compass
UnknownEarly Phase 1
Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?
United States24 participantsStarted 2019-12-18
Plain-language summary
Adolescent girls with androgen excess have a higher rate of irregular periods and decreased ovulation rates compared to normal girls, and are considered at-risk for developing polycystic ovary syndrome (PCOS). This pilot study will look at whether giving spironolactone might improve ovulation rates in girls with androgen excess, ages 13-19. If this is true, spironolactone treatment to young girls might prevent PCOS from developing and avoid future infertility.
Who can participate
Age range13 Years – 19 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:
* Girls age 13 - 19 years, with clinical or biochemical HA (defined as hirsutism and/or elevated Tanner stage-specific free testosterone concentrations) that are 4-6 years post-menarche
* Screening labs within age-appropriate normal range
* Volunteers who are 18-19 y old must be willing and able to provide written informed consent.
* When the subject is a minor (i.e., age \< 18 y), the subject and custodial parents must be willing and able to provide written informed assent and consent, respectively.
* Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of study.
Exclusion Criteria:
* Age \< 13 or \> 19 y
* Girls ≤ 3 years and ≥ 7 years post-menarche will be excluded
* Being a study of androgen excess in adolescent girls with HA, men and boys are excluded
* Inability to comprehend what will be done during the study or why it will be done
* Precocious puberty (breast development before age 7)
* Primary amenorrhea (no menses by age 16)
* BMI-for-age \< 5th percentile
* Patients currently enrolled in another research protocol will be excluded, except for those enrolled in IRB-HSR 17633 DENND1A
* Obesity due to genetic syndrome (e.g. Prader-Willi syndrome)
* Cushing syndrome
* Positive pregnancy test or 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 encoura…
What they're measuring
1
Ovulation Rate Changes
Timeframe: Rates of ovulation during weeks 17-32 (on medication) and weeks 33-48 (after medication) compared to weeks 1-16 (baseline, prior to medication)