Combined Oral Contraceptive Pill and Resistance Starch

NCT06852365 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 8568861R01HL173772-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome

Outcome Measures

Primary Outcomes (7)

• Change in LDL-C measure

  Baseline and 12 weeks

• Change in fasting glucose measure

  Baseline and 12 weeks

• Change in systolic blood pressure

  Baseline and 12 weeks

• Change in diastolic blood pressure

  Baseline and 12 weeks

• Change in BMI

  Baseline and 12 weeks

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

  Baseline and 12 weeks

• Change in Single Chain Fatty Acids (SCFA)

  Baseline and 12 weeks

Study Arms (2)

Resistant Starch

ACTIVE COMPARATOR

wheat dextrin

Dietary Supplement: wheat dextrin; Drug: Oral Contraceptives, Low-Dose

Placebo

PLACEBO COMPARATOR

maltodextrin

Drug: Oral Contraceptives, Low-Dose; Dietary Supplement: Maltodextrin

Interventions

Oral Contraceptives, Low-Dose DRUG

20 micrograms ethinyl estradiol and desogestrel 0.15mg

Placebo; Resistant Starch

Maltodextrin DIETARY_SUPPLEMENT

participants will take 15 grams per day for 12 weeks

Placebo

wheat dextrin DIETARY_SUPPLEMENT

participants will take 15 grams per day for 12 weeks

Also known as: Benefiber

Resistant Starch

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Polycystic Ovary Syndrome

Interventions

Contraceptives, Oral; maltodextrin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Central Study Contacts

Anuja Dokras, MD PhD

CONTACT

215-615-0085; adokras@pennmedicine.upenn.edu

Andrea Morley

CONTACT

215-615-4202; andrea.morley@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder's Professor in Women's Health

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-01

Locations

US (1)