PCOS showdown: metformin, inositol, or diet – which wins?
NCT ID NCT07380841
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 192 women with PCOS to see which treatment works best for improving insulin resistance and other symptoms. Participants were randomly assigned to take metformin, inositol, follow a calorie-restricted diet, or combine all three for 12 weeks. The goal was to find the most effective approach for managing PCOS and its related metabolic issues.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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192 people
The number who actually took part.
- Started
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May 2025
- Finished
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Jan 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria:Females aged 18 to 40 years. Diagnosed with polycystic ovary syndrome (PCOS) based on Rotterdam criteria (at least two of the following: oligo/anovulation, hyperandrogenism, polycystic ovaries on ultrasound). Body mass index (BMI) ≥ 18.5 kg/m². Willing to participate and provide written informed consent. Willing to comply with study procedures and follow-up visits. \- Exclusion Criteria: Pregnancy or lactation. Known diabetes mellitus, thyroid disease, hyperprolactinemia, Cushing's syndrome, or other endocrine disorders. Use of metformin, inositol, hormonal therapy, or weight-loss drugs within the last 3 months. History of renal, hepatic, or cardiovascular disease. Known hypersensitivity to metformin or inositol. Participation in another clinical trial within the last 3 months. Any serious medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation.
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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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Pakistan Institute of Health Sciences / Islamabad Medical and Dental College (IMDC)
Islamabad, Islamabad, 44000, Pakistan
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Other studies related to the condition(s) this trial covers.
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