Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin

Recruiting now · Not applicable

Conditions studied: PCOS(Insulin Resistant)

In brief

Women with polycystic ovary syndrome with HOMA-IR \>2.6 fulfilling inclusion and exclusion criteria will be randomly allocated into two groups:experimental group: A (Melatonin 3mg and Metformin 500mg) and control group: B (Metformin 500mg). Each group will be contained 30 selected patients. Group B:Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks. Outcome variables will be measured after three months, will be meticulously recorded for analysis and comparison.

Key facts

Study ID

NCT07307677

Run by

Mst.Sumyara Khatun

People needed

60

Starts

2025-03-11

Expected to finish

2026-08-10

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed case of PCOS according to Rotterdam criteria
• Women of age 18-35 years
• Insulin resistance (HOMA-IR >2.6)

You may not qualify if…

• 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 is running

• Bangladesh Medical University — Dhaka, Shahbag, Bangladesh (enrolling)

Full record on ClinicalTrials.gov

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