Clinical trials are essential for advancing evidence-based care. For clinicians with patients who have polycystic ovary syndrome (PCOS), trial outcomes provide crucial insight into potential management strategies for this disorder. Clinicians who follow trial results are better positioned to optimize therapies for their patients' unique needs.
Today, we are covering seven PCOS and PCOS-related clinical trials that completed in the previous year. These trials range in topics from treating side effects of PCOS to how progesterone affects women with PCOS.
Quick View Table of Featured PCOS Clinical Trials
| Study Title | Phase | Enrollment | Start Date | Completion Date |
|---|---|---|---|---|
| Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation | 4 | 190 | October 26, 2020 | (estimated) December 2025 |
| Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction | 2 | 60 | December 5, 2018 | February 14, 2024 |
| Comparing the Effects of Oral Contraceptive Pills Versus Metformin | 3 | 240 | January 15, 2018 | January 23, 2024 |
| Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women | 2 | 23 | April 2013 (no day given) | July 6, 2023 |
| Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea | N/A | 18 | December 2007 (no day given) | June 30, 2022 |
| Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS | N/A | 27 | October 8, 2018 | January 14, 2022 |
| Determining How Quickly Progesterone Slows LH Pulse Frequency | 1 | 85 | November 29, 2007 | January 18, 2020 |
PCOS Clinical Trials Rundown
Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation
- Sponsor: Rachel Mejia
- Goal: This study evaluates the addition of clomiphene citrate (CC) to letrozole for the treatment of infertility in women with polycystic ovary syndrome across a course of two treatment cycles with stair step dosing of letrozole similar to standard of care. Half of the participants will receive letrozole and CC in combination, while the other half will receive letrozole alone.
- Interventions: Letrozole, clomiphene citrate
- Primary Outcome Measures: Ovulation
- Timeframe: Tested six to eight days following patient reporting a positive ovulation test (LH surge). If no surge is detected, progesterone lab will be drawn on Cycle day 21-24.
- Results Posted: April 15, 2025
- Study Details
- Source
Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction
- Sponsor: University of Illinois at Chicago
- Goal: The study was a randomized, double-blind placebo-controlled study of 90 women with PCOS. Forty-five subjects with PCOS (15 lean without IR), 15 lean with IR and 15 obese) receiving salsalate, a nonacetylated salicylate, at an oral dose of 3-4 gm daily for 12 weeks will be compared with 45 age- and body-composition-matched control women with PCOS receiving placebo. The overarching hypothesis is that inflammation contributes to ovarian dysfunction, independent of excess adiposity or IR.
- Interventions: Salsalate, placebo
- Primary Outcome Measures: Aim 1: HCG-stimulated testosterone area under the curve; Aim 2: Lipid-stimulated NFkB activation.
- Timeframe: After 12 weeks of salsalate administration; After 12 weeks of salsalate or placebo administration.
- Results Posted: June 10, 2025
- Study Details
- Source
Comparing the Effects of Oral Contraceptive Pills Versus Metformin
- Sponsor: Anuja Dokras
- Goal: To determine the effect of Oral Contraceptive Pills (OCP) versus Metformin versus OCP and Metformin on the prevalence of Metabolic Syndrome (MetS) and its components in overweight/obese women with Polycystic Ovary Syndrome (PCOS).
- Interventions: OCP + metformin; OCP + placebo; metformin + placebo
- Primary Outcome Measures: Number of participants with metabolic syndrome after six months of treatment metformin or OCP+metformin for six months.
- Timeframe: Baseline and six months
- Results Posted: March 10, 2025
- Study Details
- Source
Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women
- Sponsor: University of California, Los Angeles
- Goal: The purpose of this research study was to collect specimen samples and study medical information from women with Polycystic Ovary Syndrome (PCOS) and women without PCOS. The goal was to learn more about the changes that take place in the body that result in PCOS.
- Interventions: Flutamide, placebo
- Primary Outcome Measures: Lipid content of PCOS subcutaneous (SC) abdominal adipocytes matured in vitro.
- Timeframe: Baseline, six months.
- Results Posted: January 10, 2025
- Study Details
- Source
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea
- Sponsor: University of Chicago
- Goal: The purpose of this study was to look at the metabolic (use of energy) and hormonal features of sleep problems in women with polycystic ovary syndrome (PCOS).
- Interventions: Depot Lupron followed by estrogen plus placebo
- Primary Outcome Measures: Estrogen levels; Sleep efficiency measured at baseline; total testosterone.
- Timeframe: Baseline; baseline; baseline.
- Results Posted: December 31, 2024
- Study Details
- Source
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS
- Sponsor: University of Colorado, Denver
- Goal: The investigators measured hepatic glucose and fat metabolism in obese girls with PCOS and hepatic steatosis after taking four weeks of an essential amino acid (EAA) supplement or placebo and tested whether the EAA supplement can improve hepatic glucose metabolism in these girls.
- Interventions: Essential amino acid supplement, placebo
- Primary Outcome Measures: Haptic fat fraction
- Timeframe: Four weeks after completing the first intervention, and approximately eight weeks later (four weeks washout and four weeks of second intervention).
- Results Posted: March 24, 2025
- Study Details
- Source
Determining How Quickly Progesterone Slows LH Pulse Frequency
- Sponsor: University of Virginia
- Goal: [Researchers proposed] two primary hypotheses: (1) administration of progesterone (P) (at 0600 h) to normally cycling adult women during the follicular phase will result in a demonstrable suppression of daytime luteinizing hormone (LH) (and by inference GnRH) pulse frequency within 12 hours; (2) administration of P (at 0600 h) to women with PCOS will result in less suppression of daytime LH pulse frequency than in ovulatory women without PCOS. A secondary hypothesis was that augmentation of LH amplitude after P administration will be less in PCOS compared to normal controls.
- Interventions: Oral micronized progesterone suspension, placebo
- Primary Outcome Measures: LH pulse frequency
- Timeframe: 10 hours before and after administration of micronized progesterone and placebo.
- Results Posted: March 28, 2025
- Study Details
- Source
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