Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Oral Contraceptives, Low-Dose for Metabolic Syndrome

This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of dummy treatment (placebo) to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to dummy treatment (placebo).

Official registry: https://clinicaltrials.gov/study/NCT06852365 · University of Pennsylvania · enrollment listed as 100

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are wheat dextrin, Oral Contraceptives, Low-Dose, or Maltodextrin. The registry lists allocation as randomized. This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of dummy treatment (placebo) to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to dummy treatment (placebo).

They plan to enroll about 100 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)

Interventions: wheat dextrin, Oral Contraceptives, Low-Dose, Maltodextrin

Primary outcome (registry wording): Change in LDL-C measure

Who it is for (from inclusion criteria)

  • Ages 18 Years to 40 Years
  • Women only
  • For women with more regular bleeding patterns, but who are suspected to be experiencing periodic anovulatory bleeding, a midluteal progesterone (P4) level less than 3ng/dL will be evidence of ovulatory dysfunction and qualify as anovulation
  • Women with only hyperandrogenic PCOS phenotype (hyperandrogenism + one more criteria) will be included to decrease the heterogeneity of the cohort and as metabolic risks are increased in these women compared to normo-androgenic women with PCOS
  • Subjects should be willing to avoid pregnancy for the entire duration of the study

Public study contact (from the registry)

Anuja Dokras, MD PhD

215-615-0085

adokras@pennmedicine.upenn.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06852365 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06852365?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06852365?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary