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OCP vs Metformin for Polycystic Ovarian Syndrome (COMET-PCOS Trial)

Phase 3
Waitlist Available
Led By Anuja Dokras, MD
Research Sponsored by Anuja Dokras
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with PCOS based on Rotterdam criteria with androgen excess and history of chronic anovulation and/or polycystic ovaries
Women aged ≥ 18 to ≤ 40 years with hyperandrogenic PCOS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

COMET-PCOS Trial Summary

This trial will compare the effect of OCP and metformin on MetS in overweight/obese women with PCOS.

Who is the study for?
Women aged 18-40 with PCOS, overweight (BMI of 25-48), and experiencing irregular periods can join. They must not be pregnant or planning pregnancy, have no liver/renal disease, diabetes, untreated thyroid issues or hormonal disorders, and not currently on OCPs or metformin.Check my eligibility
What is being tested?
The trial is testing the impact of Oral Contraceptive Pills (OCP), Metformin, and their combination on metabolic syndrome in women with PCOS. It aims to see how these treatments affect the risk of developing diabetes and cardiovascular diseases.See study design
What are the potential side effects?
Possible side effects include digestive issues from metformin like nausea or diarrhea; weight changes; mood swings; blood clots; increased blood pressure from OCPs; headaches; and potential skin reactions.

COMET-PCOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have PCOS with symptoms like high androgen levels and irregular periods or polycystic ovaries.
Select...
I am a woman aged 18-40 with PCOS and high male hormone levels.

COMET-PCOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prevalence of metabolic syndrome after randomizing to low dose OCP, metformin or OCP+metformin for 6 months.
Secondary outcome measures
Change in HDL-C function
Changes in lipid particle size and number
Changes in quality of life parameters in all 3 arms as assessed by PCOSQ
+4 more

COMET-PCOS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: OCP + MetforminExperimental Treatment1 Intervention
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
Group II: Metformin + PlaceboActive Control1 Intervention
Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
Group III: OCP + PlaceboActive Control1 Intervention
The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OCP + Metformin
2018
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterOTHER
494 Previous Clinical Trials
2,798,602 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,490 Total Patients Enrolled
Anuja DokrasLead Sponsor

Media Library

Metformin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03229057 — Phase 3
Polycystic Ovarian Syndrome Research Study Groups: Metformin + Placebo, OCP + Metformin, OCP + Placebo
Polycystic Ovarian Syndrome Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT03229057 — Phase 3
Metformin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03229057 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a pediatric clinical trial?

"This trial is currently recruiting patients that meet the age requirement of being between 18-40 years old."

Answered by AI

Are there other instances where OCP and Metformin have been tested together?

"As of right now, there are 180 different clinical trials underway that are researching the efficacy of OCP + Metformin. Of those, 45 have reached Phase 3. The majority of these studies are based in Rockville, Maryland; however, 1952 locations across the globe are running similar investigations."

Answered by AI

What are the primary purposes for which OCP + Metformin is prescribed?

"Oral contraceptive pills in combination with metformin is a common treatment for exercise, but it can also be used to mitigate the effects of other conditions like type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

Has the FDA cleared OCP + Metformin for use?

"The safety of OCP + Metformin was given a 3 by our analysts at Power. This is due to the fact that it is a Phase 3 trial, so while there is not yet definitive proof of efficacy, there is supporting data and multiple rounds of safety testing."

Answered by AI

Could I participate in this clinical trial if I qualify?

"This study is looking for 240 participants with polycystic ovary syndrome. Applicants must be aged 18 to 40 and meet the following criteria: Women ≥ 18 to ≤ 40 years of age (at the time of screening), with hyperandrogenic PCOS., androgen excess (defined as an elevated serum T level or hirsutism, based on a Ferriman Gallwey score > 8 (note: > 2 for women of Asian descent), history of chronic anovulation (8 or fewer periods per year), AND/OR polycystic ovaries., BMI ≥ 25 kg/m² to ≤ 48"

Answered by AI

Who else is applying?

What state do they live in?
Washington
Ohio
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Comparing the Effects of Oral Contraceptive Pills Versus Metformin
Anuja Dokras 2018. "Comparing the Effects of Oral Contraceptive Pills Versus Metformin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03229057.
~33 spots leftby Apr 2025
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