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Melatonin added to metformin for polycystic ovary syndrome with insulin resistance

Tests melatonin plus metformin versus metformin alone in women with insulin resistant polycystic ovary syndrome.

Key facts

Who runs it
Mst.Sumyara Khatun
Where
Bangladesh1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin
Status
Recruiting
People taking part
60 people, planned
Started
11 Mar 2025
Planned end
10 Aug 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Metformin 500mg
  • Melatonin 3mg
Record updated
7 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18-35 years with polycystic ovary syndrome (PCOS) and insulin resistance. They will get melatonin plus metformin, or metformin alone.

Age
18 to 35 years
Sex
Women only
Disease stage
PCOS diagnosed by the Rotterdam criteria, with insulin resistance (the body responds poorly to insulin).
Earlier treatment
No medicine that affects insulin resistance (Metformin, Myo- inositol, Pioglitazone) in the last three months.
Biomarker or test result
HOMA-IR >2.6 (a blood test score of insulin resistance).

Main reasons for not taking part

  • BMI ≤ 18.5 or ≥ 30 kg/m2
  • Uncontrolled hormone disorders such as diabetes, hypothyroidism or hyperprolactinemia
  • Known kidney, liver or heart disease
  • Use of Metformin, Myo- inositol or Pioglitazone in the last three months
  • Allergy to melatonin

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

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

Who cannot take part

  • Any medication which would affect insulin resistance (Metformin, Myo- inositol, Pioglitazone) in last three months
  • Uncontrolled endocrine disorders (Diabetis melitus, Hypothyroidism, Hyperprolactinemia)
  • Known case of any medical disease (Renal, hepatic or cardiac disease)
  • Hypersensitivity to melatonin
  • BMI: ≤ 18.5 and ≥ 30 kg/m2

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 35 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Experimental arm: Melatonin and MetforminTreatment being tested

    Participants will receive Melatonin (3mg) 3 tablet single dose at night for 12 weeks and Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks

    Treatment: Melatonin 3mg

  • Comparator arm: MetforminExisting treatment, for comparison

    Participants will receive Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks

    Treatment: Metformin 500mg

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Melatonin and Metformin Combination Therapy on Clinical and Biochemical Parameters inInsulin Resistant Polycystic Ovary Syndrome Compared to Metformin Alone
Plain-language title
Melatonin added to metformin for polycystic ovary syndrome with insulin resistanceGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07307677, who can take part
Record updated
7 January 2026