Actively Recruiting
Combined Oral Contraceptive Pill and Resistance Starch
Led by University of Pennsylvania · Updated on 2026-02-19
100
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Combined Oral Contraceptive Pill and Resistance Starch
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 40 years with a BMI between 25 and 48 kg/m2 diagnosed with PCOS by Rotterdam criteria
- Diagnosis includes chronic anovulation (8 or fewer periods), androgen excess, hirsutism, or polycystic ovaries by ultrasound or elevated AMH
- Women with more regular bleeding suspected of periodic anovulatory bleeding confirmed by midluteal progesterone less than 3 ng/dL
- Women with only hyperandrogenic PCOS phenotype (hyperandrogenism plus one more criterion) included
- Willingness to avoid pregnancy for the entire study duration
You will not qualify if you...
- Pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia, or premature menopause
- Late onset adrenal hyperplasia
- History of bariatric surgery
- Unable to comply with study procedures due to mental illness, substance abuse, or participation in other studies
- Taking medications affecting weight or metabolic parameters (e.g., lipid-lowering drugs)
- History of Crohn's disease or ulcerative colitis, current use of probiotics or laxatives
- Antibiotic use within 3 months prior to randomization
- Dietary fiber intake over 20 g/day based on pre-screening survey
- Medical conditions contraindicating oral contraceptive use or other conditions such as type 1 or 2 diabetes, liver or kidney disease, severe anemia, alcohol abuse, poorly controlled hypertension, high triglycerides, chronic inflammatory conditions, history of blood clots or heart disease, and certain cancers or hormone-secreting tumors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Anuja Dokras, MD PhD
CONTACT
A
Andrea Morley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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