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Recruiting

NCT Number: NCT06852365

Combined Oral Contraceptive Pill and Resistance Starch

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 placebo to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to placebo.

Recruiting

Interested in participating?

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Andrea Morley

CONTACT

[email protected]

215-615-4202

Anuja Dokras, MD PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women between ages of 18-40 years with BMI greater than or equal to 25 kg/m² to less than or equal to 48 kg/m² diagnosed with PCOS defined by the Rotterdam criteria based on a history of chronic anovulation (8 or fewer periods), androgen excess [defined as total serum testosterone, free testosterone or a FAI greater than or equal to 90% of the upper limit of normal) or hirsutism (Ferriman-Gallwey score greater than 6 for Hispanics/ Black and greater than or equal to 2 for women of Asian descent)] and polycystic ovaries as defined by a pelvic ultrasound (20 or more follicles or ovarian vol greater than 10cm3) or elevated AMH.
  • 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.

Exclusion criteria

  • Subjects with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature menopause.
  • Subjects with late onset adrenal hyperplasia
  • Subjects with history of bariatric surgery
  • Those who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.
  • Subjects taking medications that affect weight or metabolic parameters (e.g. lipid lowering medications).
  • History of Crohn's disease and ulcerative colitis as well as current use of probiotics and laxatives are excluded.
  • Subjects could not have taken antibiotics for at least 3 months prior to randomization visit.
  • Subjects with greater than 20 g/day of dietary fiber intake based on pre-screening ASA-24 survey will be excluded.
  • Subjects with medical conditions that are contraindications to use of OCP and other medical conditions such as:
  • Type 1 or 2 diabetes
  • liver disease or dysfunctional liver (AST/ALT greater than 2x normal or a total bilirubin greater than 2.5 mg/dL)
  • renal disease (BUN greater than 30 mg/dL or serum creatinine greater than 1.4 mg/dL)
  • severe anemia (hemoglobin less than 10 mg/dL)
  • alcohol abuse
  • poorly controlled hypertension
  • TG greater than 250 mg/dl
  • chronic inflammatory conditions such as psoriasis
  • history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; known heart disease (New York Heart Association Class II or higher)
  • history of cervical carcinoma, endometrial carcinoma, or breast carcinoma, adrenal or ovarian tumor secreting androgens, and Cushing's syndrome -

Treatment and study plan

wheat dextrin

Dietary Supplement

participants will take 15 grams per day for 12 weeks

Other names: Benefiber

Oral Contraceptives, Low-Dose

Drug

20 micrograms ethinyl estradiol and desogestrel 0.15mg

Maltodextrin

Dietary Supplement

participants will take 15 grams per day for 12 weeks

Primary outcomes

  1. Change in LDL-C measure

    Time frame: Baseline and 12 weeks

  2. Change in fasting glucose measure

    Time frame: Baseline and 12 weeks

  3. Change in systolic blood pressure

    Time frame: Baseline and 12 weeks

  4. Change in diastolic blood pressure

    Time frame: Baseline and 12 weeks

  5. Change in BMI

    Time frame: Baseline and 12 weeks

  6. Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR)

    Time frame: Baseline and 12 weeks

  7. Change in Single Chain Fatty Acids (SCFA)

    Time frame: Baseline and 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Morley

CONTACT

[email protected]

215-615-4202

Anuja Dokras, MD PhD

CONTACT

[email protected]

215-615-0085

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: COR-PCOS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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