Oral Contraceptives + Resistant Starch for Polycystic Ovary Syndrome

(COR-PCOS Trial)

Overseen By Andrea Morley

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Pennsylvania

Must be taking: Oral contraceptives

Must not be taking: Lipid lowering, Probiotics, Laxatives, Antibiotics

Disqualifiers: Diabetes, Liver disease, Renal disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 4 6 7}

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

I have PCOS with high male hormone levels only.

Subjects willing to avoid pregnancy for the entire duration of the study

I may have irregular periods due to low progesterone.

Exclusion Criteria

My irregular periods are not due to pregnancy, breastfeeding, thyroid issues, high prolactin levels, or early menopause.

Subjects unable to comply with the study procedures due to mental illness, substance abuse, or participation in other studies

Subjects with greater than 20 g/day of dietary fiber intake

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral contraceptive pills followed by either 12 weeks of resistant starch or 12 weeks of placebo

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Oral Contraceptives
• Resistant Starch

Trial Overview The study tests if adding resistant starch to standard low-dose oral contraceptives can improve heart health and gut balance in women with PCOS. It compares 12 weeks on resistant starch versus a placebo, alongside contraceptive use.

Participant Groups

Group I: Resistant Starch Active Control 2 Interventions

wheat dextrin

Group II: Placebo Placebo Group 2 Interventions

maltodextrin

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a study of 119 women with polycystic ovary syndrome (PCOS), persistence rates for oral contraceptive pills (OCPs) and metformin were similar at 3 months (57.1% for OCPs vs. 57.8% for metformin), indicating both treatments are equally accepted initially.

However, persistence with both treatments significantly declined over time, with only 21.7% continuing OCPs and 31.2% continuing metformin at 12 months, highlighting a challenge in long-term adherence to treatment for PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistence with oral contraceptive pills versus metformin in women with polycystic ovary syndrome. Karjane, NW., Cheang, KI., Mandolesi, GA., et al.[2022]

In a systematic review of 14 randomized controlled trials involving 707 nonobese women with PCOS, the combination of oral contraceptives (OCs) and metformin significantly improved fasting glucose and insulin levels compared to OCs alone.

While the combination treatment enhanced glucose metabolism, it did not show significant differences in other metabolic markers like cholesterol or insulin resistance, suggesting that metformin specifically benefits glucose regulation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral contraceptives (OCs) in combination with metformin versus OCs alone on metabolism in nonobese polycystic ovary syndrome: A meta-analysis and systematic review of randomized controlled trials. Wu, L., Liu, Y., Huang, X., et al.[2023]

In a study of 60 women with PCOS, the combination of the contraceptive pill Diane35 and metformin was more effective in reducing hyperandrogenemia and insulin levels compared to metformin alone, suggesting a synergistic effect in managing PCOS symptoms.

Diane35 restored menstrual regularity in all patients, while metformin significantly reduced body mass index and waist-to-hip ratio in obese patients, highlighting the distinct benefits of each treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of metformin and ethinyl estradiol-cyproterone acetate on clinical, endocrine and metabolic factors in women with polycystic ovary syndrome. Wu, J., Zhu, Y., Jiang, Y., et al.[2013]

Targeting insulin resistance in women with PCOS can lead to significant improvements in hormonal balance, metabolism, and ovulation, which may enhance fertility.

The treatment approach for PCOS should be personalized based on individual factors such as age, degree of androgen excess, presence of obesity, and fertility desires, with options including lifestyle changes, insulin sensitizers like metformin, and hormonal therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting insulin sensitivity in the treatment of polycystic ovary syndrome. Pasquali, R., Gambineri, A.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Persistence with oral contraceptive pills versus metformin in women with polycystic ovary syndrome. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Oral contraceptives (OCs) in combination with metformin versus OCs alone on metabolism in nonobese polycystic ovary syndrome: A meta-analysis and systematic review of randomized controlled trials. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The association between the combined oral contraceptive pill and insulin resistance, dysglycemia and dyslipidemia in women with polycystic ovary syndrome: a systematic review and meta-analysis of observational studies. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effect of ethinylestradiol/cyproterone acetate on endothelial function in young non-obese women with polycystic ovary syndrome: a pilot study. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Influence of oral contraceptives on anthropomorphometric, endocrine, and metabolic profiles of anovulatory polycystic ovary syndrome patients. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Effects of metformin and ethinyl estradiol-cyproterone acetate on clinical, endocrine and metabolic factors in women with polycystic ovary syndrome. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Targeting insulin sensitivity in the treatment of polycystic ovary syndrome. [2013]