The Supporting Understanding of PCOS Education and Research (SUPER) Study (NCT05452642) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Supporting Understanding of PCOS Education and Research (SUPER) Study
United States223 participantsStarted 2022-08-15
Plain-language summary
This research will test whether a Dietary Approaches to Stop Hypertension (DASH) or a very low-carbohydrate diet better improves outcomes like blood glucose control and body weight for adults with polycystic ovary syndrome.
Participants will have screening (includes blood draw) and baseline testing with a continuous glucose monitor and a body composition scan (called a dual-energy x-ray absorptiometry or DEXA). Once these enrollment steps are completed and the participants will be randomized to one of two 12-month programs.
Who can participate
Age range
21 Years – 45 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:
* Participants must have the following criteria:
* oligomenorrhea-anovulation
* spontaneous intermenstrual periods (if not on hormonal birth control or birth control that alters menstrual cycle timing) of \< 21 days or \> 35 days or a total of 8 or fewer menses per year
* if on hormonal birth control or birth control that alters menstrual cycle timing, a history of irregular periods
* and hyperandrogenism
* If not on hormonal birth control or birth control that alters menstrual cycle timing: Total testosterone ≥ 35 ng/dL OR free testosterone \> 4.0 pg/ml OR free androgen index \> 1.5 OR in-person scoring for hirsutism, based on the modified Ferriman-Gallwey score, if attending an in-person assessment or based on the self-assessment (if not attending an in-person assessment) with a score of ≥ 4 considered hirsutism;
* If on hormonal birth control or birth control that alters menstrual cycle timing: Tests within the past 10 years showing the above or study team's in-person assessment of hirsutism as above.
* If no medical records to confirm (most recent test from within the last 10 years in range), tests for diagnosis will be ordered:
* total testosterone \< 100 ng/dL,
* dehydroepiandrosterone sulfate (DHEAS) \< 600 μg/dL,
* fasting 17-hydroxyprogesterone (17-OHP) level \< 2.0 ng/mL,
* prolactin \< 25 ng/ml),
* follicle-stimulating hormone (FSH) levels \< 20 mIU/mL
* BMI 25-50 kg/m2 or 23-50 kg/m2 for Asians
* Access to int…
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.