Polycystic Ovary Syndrome (PCOS) significantly affects patient quality of life, with fertility impairment being a major clinical concern. Given its broad effects on reproductive, metabolic, and psychological health, it is essential for clinicians managing patients living with PCOS to remain current with emerging clinical evidence.
Ongoing awareness of active and upcoming clinical trials enables clinicians to inform patients about potential access to new therapies and treatment strategies. Today, we have an overview of five clinical trials for patients with PCOS that are currently recruiting or expected to begin enrollment soon.
Overview Table of PCOS Clinical Trials
| Study Title | Phase | Recruitment Status | Estimated Enrollment | Start Date | Estimated Primary Completion |
|---|---|---|---|---|---|
| Combined Oral Contraceptive Pill and Resistance Starch (COR-PCOS) | 2 | Recruiting | 100 | June 2025 | April 2028 |
| Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy | 1 | Not Yet | 85 | January 2025 | January 2026 |
| Bicalutamide Therapy in Young Women with NAFLD and PCOS | 1 | Recruiting | 50 | February 2024 | August 2028 |
| Role of Semaglutide in Restoring Ovulation in Youth and Adults with Polycystic Ovary Syndrome (RESTORE) | 3 | Recruiting | 80 | November 2023 | February 2028 |
| Inositol Supplementation to Treat PCOS (INSUPP-PCOS) | 2 | Recruiting | 154 | January 2020 | December 2025 |
PCOS Clinical Trials Rundown
Combined Oral Contraceptive Pill and Resistance Starch (COR-PCOS)
- Sponsor: University of Pennsylvania
- Goal: 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.
- Interventions: Wheat dextrin, oral contraceptives: low dose, maltodextrin
- Primary Outcome Measures: Change in LCL-C measure, change in fasting glucose measure, change in systolic blood pressure, change in diastolic blood pressure, change in BMI, change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR), change in single chain fatty acids (SCFA)
- Time Frame: Baseline and 12 weeks for all outcome measures.
- Study Details
- Source
Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy
- Sponsor: Methodist Health System
- Goal: The purpose of this study is to investigate the effect of semaglutide in women with Polycystic Ovarian Syndrome(PCOS ) and determine potential therapeutic benefits.
- Interventions: Semaglutide
- Primary Outcome Measures: Number of appropriate weekly dose, number of days on therapy
- Time Frame: Four weeks for both outcome measures
- Study Details
- Source
Bicalutamide Therapy in Young Women with NAFLD and PCOS
- Sponsor: University of California, San Francisco
- Goal: This study will study the contribution of androgens to liver injury and progression in PCOS and mechanistic role of dysregulated lipid metabolism and visceral adiposity in this process.
- Interventions: Bicalutamide 50 mg, placebo
- Primary Outcome Measure: Change in liver stiffness on magnetic resonance elastography (MRE)
- Time Frame: Baseline and six months
- Study Details
- Source
Role of Semaglutide in Restoring Ovulation in Youth and Adults with Polycystic Ovary Syndrome (RESTORE)
- Sponsor: University of Colorado, Denver
- Goal: After a 4-month observation period of either no medication or metformin treatment, females aged 12-35 years with obesity and polycystic ovary syndrome will receive 10 months of a glucagon-like peptide-1 receptor agonist to induce metabolic changes, weight loss and improve reproductive abnormalities.
- Interventions: Semaglutide injectable product (Wegovy and/or Ozempic)
- Primary Outcome Measure: Change in ovulation frequency before and after semaglutide in females with PCOS
- Time Frame: 14 months
- Study Details
- Source
Inositol Supplementation to Treat PCOS (INSUPP-PCOS)
- Sponsor: Milton S. Hershey Medical Center
- Goal: To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with polycystic ovarian syndrome (PCOS).
- Interventions: Placebo, inositol
- Primary Outcome Measure: Change in total testosterone
- Time Frame: Baseline and three months
- Study Details
- Source
Related Guidance:
- Centre for Research Excellence in Polycystic Ovary Syndrome, 2023
- American College of Obstetricians and Gynecologists, 2018
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