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New treatment option for Metabolic Syndrome
Official title Combined Oral Contraceptive Pill and Resistance Starch
ClinicalTrials.gov ID: NCT06852365
What this study is testing
What is Oral Contraceptives, Low-Dose?
Oral Contraceptives, Low-Dose is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metabolic syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join 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...
- For women with more regular bleeding patterns, but who are suspected to be experiencing periodic anovulatory bleeding, a midluteal progesterone (P4)...
- Women with only hyperandrogenic PCOS phenotype (hyperandrogenism + one more criteria) will be included to decrease the heterogeneity of the cohort...
- people should be willing to avoid pregnancy for the entire duration of the study.
You likely can't join if
- people with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature...
- people with late onset adrenal hyperplasia
- people 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.
- people 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.
See the full eligibility criteria
- 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...
- 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...
- 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...
- people should be willing to avoid pregnancy for the entire duration of the study.
- people with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature menopause.
- people with late onset adrenal hyperplasia
- people 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.
- people 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.
- people could not have taken antibiotics for at least 3 months prior to randomization visit.
- people with greater than 20 g/day of dietary fiber intake based on pre-screening ASA-24 survey will be excluded.
- people 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
- TG greater than 250 mg/dl
- chronic inflammatory conditions such as psoriasis
- history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; known heart disease (New York Heart Association Class II or higher)
- history of cervical carcinoma, endometrial carcinoma, or breast carcinoma, adrenal or ovarian tumor secreting androgens, and Cushing's syndrome -
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.