Can metformin plus coaching reshape PCOS health?
NCT ID NCT07811856
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Polycystic ovary syndrome (PCOS) often comes with insulin resistance, cholesterol problems, and other metabolic issues. Researchers are testing whether metformin, a common diabetes drug, changes metabolic, vitamin B12, iron, and blood measures in women with PCOS, and whether adding a structured behavioral education program makes a difference. The trial enrolls 900 women aged 18 to 40 with a confirmed PCOS diagnosis. Participants receive placebo, metformin alone, or metformin plus five sessions on diet, activity, sleep, stress, and self-management, with measurements taken at the start and after six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin, a common diabetes drug, given alone or alongside a behavioral education program
- What this could lead to
- If the combination helps, it could give women with PCOS a clearer plan for managing metabolism, weight, and blood health through both medication and structured lifestyle coaching.
- What could go wrong
- Metformin is already widely used, so the main question is whether adding education changes anything beyond the drug alone. Results may not apply to all women with PCOS, and metformin can cause stomach upset and lower vitamin B12 over time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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900 people
The number who actually took part.
- Started
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Aug 2026
- Finished
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Aug 2026
- Lead sponsor
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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
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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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 aged 18-40 years. 2. Specialist-confirmed diagnosis of polycystic ovary syndrome (PCOS). 3. Ability and willingness to participate in the six-month study follow-up. 4. Ability to comply with the study procedures and assessments. Exclusion Criteria: 1. Chronic hemolytic anemia. 2. Chronic kidney disease. 3. Hepatic disorders. 4. Other endocrine, metabolic, or cardiovascular conditions that could affect glucose metabolism, vitamin B12 status, iron status, erythropoietin levels, or hematological parameters. 5. Previous use of insulin-sensitizing medications other than the study metformin. 6. Current or recent hormonal therapy that could affect the study outcomes. 7. Current use of iron or vitamin B12 supplements. 8. Use of medications that could substantially affect glucose metabolism, vitamin B12 status, iron status, erythropoietin levels, or hematological parameters. 9. Any condition that could interfere with adherence to the intervention or completion of the six-month follow-up.
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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
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Jerash University
Amman, 009627, Jordan
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Other studies related to the condition(s) this trial covers.