Combined Oral Contraceptive Pill and Resistance Starch

Recruiting Phase 2 Interventional Study
Metabolic Syndrome Polycystic Ovary Syndrome
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 40
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
100 (estimated)
Sponsor
University of Pennsylvania · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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 testos…
Contacts

Anuja Dokras, MD PhD

215-615-0085

adokras@pennmedicine.upenn.edu

CONTACT

Andrea Morley

215-615-4202

andrea.morley@pennmedicine.upenn.edu

CONTACT