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Combined Oral Contraceptive Pill and Resistance Starch

NCT06852365 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-19

No results posted yet for this study

Summary

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

  • Metabolic Syndrome
  • Polycystic Ovary Syndrome

Interventions

DIETARY_SUPPLEMENT

wheat dextrin

participants will take 15 grams per day for 12 weeks

DRUG

Oral Contraceptives, Low-Dose

20 micrograms ethinyl estradiol and desogestrel 0.15mg

DIETARY_SUPPLEMENT

Maltodextrin

participants will take 15 grams per day for 12 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06852365 on ClinicalTrials.gov