Oral Contraceptives + Resistant Starch for Polycystic Ovary Syndrome
(COR-PCOS Trial)
Trial Summary
Do I need to stop taking my current medications for this trial?
The trial requires that participants do not take medications that affect weight or metabolic parameters, such as lipid-lowering medications. If you are on such medications, you may need to stop them to participate.
Is the combination of oral contraceptives and resistant starch safe for humans?
Oral contraceptives are commonly used and generally considered safe, but they may affect metabolism, potentially worsening blood sugar and cholesterol levels in women with polycystic ovary syndrome (PCOS). There is no specific safety data available for the combination of oral contraceptives and resistant starch.12345
How does the drug Oral Contraceptives + Resistant Starch differ from other treatments for polycystic ovary syndrome?
This treatment is unique because it combines oral contraceptives, which are commonly used to manage symptoms of polycystic ovary syndrome (PCOS), with resistant starch, a type of dietary fiber that may help improve insulin sensitivity and metabolic health. This combination aims to address both hormonal and metabolic aspects of PCOS, potentially offering a more comprehensive approach than oral contraceptives alone.23467
What is the purpose of 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.
Eligibility Criteria
This trial is for women with Polycystic Ovary Syndrome (PCOS) who are interested in exploring the effects of oral contraceptive pills combined with resistant starch. Participants should not have other significant health issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral contraceptive pills followed by either 12 weeks of resistant starch or 12 weeks of placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Oral Contraceptives
- Resistant Starch
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator