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Birth control pills or metformin: which works better for PCOS?

NCT ID NCT03229057

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 240 overweight or obese women with PCOS to see if birth control pills, metformin, or a combination of both is best for reducing metabolic syndrome—a cluster of conditions that raise the risk for diabetes and heart disease. Participants took one of the three treatments for six months. The goal was to find out which approach improves health markers like waist size, blood pressure, and cholesterol.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral contraceptive pills and metformin
What this could lead to
If successful, this study could show that combining OCP and metformin reduces metabolic syndrome risk in women with PCOS, potentially lowering their chances of diabetes and heart disease.
What could go wrong
This trial is completed but results may not apply to all women with PCOS. The 6-month treatment period is short, and long-term benefits or risks are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

240 people

The number who actually took part.

Started

Jan 2018

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Women ≥ 18 to ≤ 40 years of age (at the time of screening), with hyperandrogenic PCOS. 2. Subjects will be diagnosed with PCOS defined by the most recent Rotterdam criteria based on: 1. 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) AND either: 2. history of chronic anovulation (8 or fewer periods per year) AND/OR 3. polycystic ovaries. 3. BMI ≥ 25 kg/m² to ≤ 48 kg/m² obtained at screening visit. 4. In good general health. 5. Willing to avoid pregnancy for the duration of the study. Exclusion Criteria: 1. Current pregnancy or desire of pregnancy during course of study 2. Currently breastfeeding 3. Known 21 hydroxylase deficiency 4. Untreated thyroid disease (TSH \<0.45 mlU/mL and \> 4.5 mlU/mL) 5. Untreated hyperprolactinemia (2 Levels\>30 ng/ml at least one week apart) 6. Type 1 or type 2 Diabetes Mellitus (elevated fasting serum glucose \>126mg/dL on two occasions, poorly controlled diabetes (HgbA1C\>6.5%), currently receiving anti-diabetic agents, or currently receiving metformin for treatment of diabetes 7. Liver disease (AST/ALT\>2 times normal or a total bilirubin \>2.5 mg/dL) 8. Renal disease (BUN\>30 mg/dL or serum creatinine \>1.4 mg/dL) 9. Anemia (hemoglobin \<10 mg/dL) 10. History of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident 11. Current history of alcohol abuse (\>14drinks/week) 12. Poorly controlled hypertension defined as average systolic blood pressure \>= 150 mm Hg or average diastolic \>=100 mm Hg obtained on three measurements obtained 5 minutes apart. If treated, average systolic blood pressure \>=140 mm Hg or average diastolic \>=90 mm Hg 13. Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma 14. TG\>200mg/dl 15. Use of lipid lowering or weight loss agents (subjects may wash out from weight loss agents) 16. Current use of oral contraceptives, depo progestin, or hormonal implants 17. Participation in any study of an investigational drug or device or biological agent within 30 days 18. Suspected adrenal or ovarian tumor secreting androgens 19. Suspected Cushing's syndrome 20. Bariatric surgery procedure in the recent past (\<12 months) 21. Absolute contraindications to the use of hormonal contraceptives or metformin, 23\. Subjects who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Penn State/ Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.