Effect of Pioglitazone vs Metformin on Clinical, Biochemical and Hormonal Parameters of Insulin Resistant PCOS (PCOS HOMA IR)

Effect of Pioglitazone on Clinical, Biochemical and Hormonal Parameters of Insulin Resistant PCOS in Comparison to Metformin

Women with PCOS with HOMA-IR >2 fulfilling inclusion and exclusion criteria are randomly allocated into two groups: group A: pioglitazone 30 mg once daily and group B: Metformin 500 thrice daily for 3 months.Each group contains 30 participants. Outcome variables are measured after 3 months.

Study Overview

• Status: Completed
• Conditions: PCOS(Insulin Resistant)
• Intervention / Treatment: Drug: Pioglitazone 30 Mg Oral Tablet; Drug: metformin 500 mg thrice daily

Detailed Description

This study will be conducted in the Department of Reproductive Endocrinology and Infertility, Bangladesh Medical University from the day of IRB approval. Ethical clearance will be obtained from the Institutional Review Board. Selection of the patients will be done according to inclusion and exclusion criteria. Insulin resistant PCOS patients will be included only. The patients will be explained in details regarding the objectives, rationality and potential benefits of the study. The patients will be counseled regarding the drugs and unexpected side-effect and an informed written consent will be taken. Data will be collected through interview, physical examinations and laboratory investigations. All the data will be enrolled in the data sheet for this study. The random sequence generation of permuted block will be done by computer-generated random numbers. Eligible women will be randomized to either pioglitazone group (Group A) or metformin group (Group B).

Allocation concealment will be done using serially numbered closed opaque envelopes.

Each envelope will have a card inside noting the intervention drug. Allocation will not be changed after opening the closed envelopes.

Group A: Participants will receive Tab. Pioglitazone 30mg once daily for 12 weeks.

Group B: Participants will receive Tab. Metformin 500mg thrice daily for 12 weeks.

At first baseline height, weight, waist circumference and hip circumference will be measured and BMI and waist hip ratio will be calculated. Then baseline Fasting blood glucose, Fasting insulin, Serum FSH, Serum LH, Serum Total Testosterone, Sex Hormone Binding Globulin (SHBG) will be done by collecting 5 ml blood from patient's anti cubital vein in 2nd day of menstruation and then HOMA-IR index and Free Androgen Index will be calculated. All participants will be instructed not to take any medications during the study except after consulting the physician. After 12 weeks of treatment, again BMI, waist circumference, hip circumference and waist hip ratio will be calculated and FBS, Fasting insulin, Serum FSH, Serum LH, Serum Total Testosterone, Sex Hormone Binding Globulin (SHBG) will be done and HOMA-IR index and Free Androgen Index will be calculated. Clinical record form will be developed after pre-testing. The structured clinical record form (appendix I) will include domains like demographic data, eligibility checklist visit pages (baseline, 3 month follow up) & adverse event log. The items will be demographic, clinical and laboratory variables. The form will be filled up by principal investigator. The cumulative data will be subjected to analysis.

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• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Shahbag
    • Dhaka, Shahbag, Bangladesh, 1000
      • Bangladesh Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Diagnosed case of PCOS patients according to Rotterdam criteria
• HOMA-IR >2 (Hydrie et al., 2012)
• Age: 18-35 years
• BMI: 18.5 -27.5 kg/m²

Exclusion criteria:

• Presence of any endocrine disorder (hyperthyroidism, hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, hyperprolactinaemia, diabetes mellitus).
• Presence of any medical comorbidity (renal, hepatic and cardiovascular disease)
• Any medication in the last three months which would affect insulin resistance (metformin, oral contraceptive pill)
• Any contraindications to Pioglitazone (Patients with a known hypersensitivity to pioglitazone or any of its components, Diabetic ketoacidosis or type 1 diabetes) or Metformin (severe chronic diseases e.g. hepatic, renal and cardiac failure or acute complications of diabetes e.g. ketoacidosis and hyperosmolar state).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; pioglitazone 30 mg once daily	Drug: Pioglitazone 30 Mg Oral Tablet; pioglitazone 30 mg once daily for 3 months; Drug: metformin 500 mg thrice daily; tab. Metformin 500 mg given 3 times daily for 3 months
Active Comparator: Comparator arm; metformin 500mg thrice daily for 3 months	Drug: Pioglitazone 30 Mg Oral Tablet; pioglitazone 30 mg once daily for 3 months; Drug: metformin 500 mg thrice daily; tab. Metformin 500 mg given 3 times daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biochemical parameters of insulin resistant PCOS	Biochemical: 1. HOMA-IR	baseline to 3 months
clinical parameter	waist hip ratio	3 months
hormonal parameter	free androgen index	3 months

Collaborators and Investigators

• Sponsor: Mst.Sumyara Khatun
• Collaborators: Bangladesh Medical University
• Investigators: Study Chair: Farzana Deeba, MBBS,FCPS,MS,MRCOG, Bangladesh Medical University; Principal Investigator: Ismat Jahan Kumkum, MBBS, Bangladesh Medical University

Publications and helpful links

General Publications

• Sangeeta S
• Zhao H, Zhang J, Xing C, Cheng X, He B. Metformin versus metformin plus pioglitazone on gonadal and metabolic profiles in normal-weight women with polycystic ovary syndrome: a single-center, open-labeled prospective randomized controlled trial. J Ovarian Res. 2024 Feb 19;17(1):42. doi: 10.1186/s13048-024-01367-7.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Actual): December 12, 2025
• Study Completion (Actual): February 20, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Dosage Forms; Thiazoles; Azoles; Biguanides; Guanidines; Amidines; Thiazolidinediones; Pioglitazone; Metformin; Tablets
• Other Study ID Numbers: 5161 (Other Identifier: Clinical Trials Ontario)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No