Nightly melatonin added to metformin for women with insulin-resistant PCOS
Official title: Effect of Melatonin and Metformin Combination Therapy on Clinical and Biochemical Parameters inInsulin Resistant Polycystic Ovary Syndrome Compared to Metformin Alone
Run by Bangladesh Medical University · NCT07307677 · Data updated 2026-11-12
This test will see if adding nightly melatonin to standard metformin helps women aged 18–35 with insulin-resistant PCOS improve metabolic and clinical measures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 35 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Bangladesh Medical University Academic / other |
| Locations | 1 site (Dhaka, Shahbag) |
| Status | Recruiting |
| Started | March 11, 2025 |
| Main results expected | March 10, 2026 |
| Study ends | August 10, 2026 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT07307677 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–35 diagnosed with PCOS by Rotterdam criteria who have insulin resistance (HOMA-IR >2.6), BMI between 18.5 and 30 kg/m2, and no recent use of insulin-sensitizing medications are ideal candidates.
✕Probably not a fit
Women with BMI ≤18.5 or ≥30 kg/m2, uncontrolled endocrine disorders, major renal/hepatic/cardiac disease, recent use of metformin/myo-inositol/pioglitazone, or known melatonin hypersensitivity are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized controlled trial at Bangabandhu Sheikh Mujib Medical University enrolling 60 women with PCOS and HOMA-IR >2.6. Participants are randomized to receive either melatonin 3 mg nightly plus metformin (titrated to 500 mg three times daily) or metformin alone for 12 weeks. Clinical exams, interviews, and laboratory tests will be done at baseline and after three months to compare biochemical and clinical outcomes. Randomization uses sealed opaque envelopes and informed consent is obtained from all participants.
Why it matters
Potential benefit: If successful, adding melatonin could improve insulin sensitivity and related clinical or biochemical markers in women with insulin-resistant PCOS.
How similar studies have gone: Small prior studies have reported some benefits of melatonin on oxidative stress and hormonal parameters in PCOS, but larger randomized evidence combining melatonin with metformin is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed case of PCOS according to Rotterdam criteria * Women of age 18-35 years * Insulin resistance (HOMA-IR \>2.6) Exclusion Criteria: * BMI: ≤ 18.5 and ≥ 30 kg/m2 * Uncontrolled endocrine disorders (Diabetis melitus, Hypothyroidism, Hyperprolactinemia) * Known case of any medical disease (Renal, hepatic or cardiac disease) * Any medication which would affect insulin resistance (Metformin, Myo- inositol, Pioglitazone) in last three months. * Hypersensitivity to melatonin.
Where it's running
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Bangladesh Medical University
Dhaka, Shahbag, Bangladesh Recruiting
Study contacts
- Principal investigator: Farzana Rahman, MBBS — Bangladesh Medical University
- Study coordinator: Mst.Sumyara Khatun, MS
- Email: sumirmc09@gmail.com
- Phone: +8801746046581
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.