NCT06852365 · University of Pennsylvania
Combined Oral Contraceptive Pill and Resistance Starch
(COR-PCOS)
What this study is about
This study will enroll women with PCOS to study the effects of first line therapy, taken by mouth 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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
wheat dextrin
participants will take 15 grams per day for 12 weeks
DRUG
Oral Contraceptives, Low-Dose
20 micrograms ethinyl estradiol and desogestrel 0.15mg
DIETARY_SUPPLEMENT
Maltodextrin
participants will take 15 grams per day for 12 weeks
Primary outcome measures
Change in LDL-C measure
Time frame: Baseline and 12 weeks
Change in fasting glucose measure
Time frame: Baseline and 12 weeks
Change in systolic blood pressure
Time frame: Baseline and 12 weeks
Change in diastolic blood pressure
Time frame: Baseline and 12 weeks
Change in BMI
Time frame: Baseline and 12 weeks
Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR)
Time frame: Baseline and 12 weeks
Change in Single Chain Fatty Acids (SCFA)
Time frame: Baseline and 12 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 -
Where
- Philadelphia, Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations