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 range
13 Years – 19 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)