Birth control pills or metformin: which works better for PCOS?
NCT ID NCT03229057
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for PCOS are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Could a higher dose of letrozole unlock fertility for women with PCOS?
- Can PCOS change the brain? scientists look inside for answers
- New PCOS study aims to map hidden patterns of the condition
- Hormone link to fatty liver in young women under microscope
- New combo may boost fertility in PCOS patients
- Could a prostate cancer drug help women with fatty liver and PCOS?