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

NCT07307677 | Recruiting

• 1 other identifier: 5498
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PCOS(Insulin Resistant)

Keywords

Melatonin in PCOS

Outcome Measures

Primary Outcomes (1)

• Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  HOMA-IR calculated by the following formula: HOMA-IR= Fasting glucose (mmol/L) x Fasting insulin mIU/ml divided by 22.5. For the present study HOMA-IR \>2.6 can be considered as insulin resistance

  Baseline to 12 weeks

Secondary Outcomes (2)

• Change in Body Mass Index (BMI)

  Baseline to 12 weeks

• Change in Waist Circumference

  Baseline to 12 weeks

Study Arms (2)

Experimental arm: Melatonin and Metformin

EXPERIMENTAL

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

Combination Product: Melatonin 3mg

Comparator arm: Metformin

ACTIVE COMPARATOR

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

Drug: Metformin 500mg

Interventions

Metformin 500mg DRUG

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

Comparator arm: Metformin

Melatonin 3mg COMBINATION_PRODUCT

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

Experimental arm: Melatonin and Metformin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Mst.Sumyara Khatun: lead
• Bangladesh Medical University: collaborator

Study Sites (1)

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

RECRUITING

Related Publications (2)

• Chen W, Zhang H, Guo B, Tao Y, Zhang J, Wang J, Chen G, Cheng M, Hong Q, Cao Y, Xie F. Melatonin refines ovarian mitochondrial dysfunction in PCOS by regulating the circadian rhythm gene Clock. Cell Mol Life Sci. 2025 Mar 6;82(1):104. doi: 10.1007/s00018-025-05609-9.

  PMID: 40047877 BACKGROUND

• Ziaei S, Hasani M, Malekahmadi M, Daneshzad E, Kadkhodazadeh K, Heshmati J. Effect of melatonin supplementation on cardiometabolic risk factors, oxidative stress and hormonal profile in PCOS patients: a systematic review and meta-analysis of randomized clinical trials. J Ovarian Res. 2024 Jul 4;17(1):138. doi: 10.1186/s13048-024-01450-z.

  PMID: 38965577 BACKGROUND

MeSH Terms

Interventions

Metformin; Melatonin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jesmine Banu, MS

  Bangladesh Medical University

  STUDY CHAIR

• Farzana Rahman, MBBS

  Bangladesh Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mst.Sumyara Khatun, MS

CONTACT

+8801746046581; sumirmc09@gmail.com

Farzana Rahman, MBBS

CONTACT

+8801914229346; farzana47arshi91@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Officer

Model Details: Open label parallel design randomized clinical trial

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: March 11, 2025
• Primary Completion: March 10, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)