Effect of Pioglitazone vs Metformin on Clinical, Biochemical and Hormonal Parameters of Insulin Resistant PCOS

NCT07472179 | Completed

• 1 other identifier: 5161
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PCOS(Insulin Resistant)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Experimental arm

EXPERIMENTAL

pioglitazone 30 mg once daily

Drug: Pioglitazone 30 Mg Oral Tablet; Drug: metformin 500 mg thrice daily

Comparator arm

ACTIVE COMPARATOR

metformin 500mg thrice daily for 3 months

Drug: Pioglitazone 30 Mg Oral Tablet; Drug: metformin 500 mg thrice daily

Interventions

Pioglitazone 30 Mg Oral Tablet DRUG

pioglitazone 30 mg once daily for 3 months

Comparator arm; Experimental arm

metformin 500 mg thrice daily DRUG

tab. Metformin 500 mg given 3 times daily for 3 months

Comparator arm; Experimental arm

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

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

Location

Related Publications (2)

• Sangeeta S

  BACKGROUND

• 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.

  PMID: 38374053 BACKGROUND

MeSH Terms

Interventions

Pioglitazone; Tablets; Metformin

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines

Study Officials

• Farzana Deeba, MBBS,FCPS,MS,MRCOG

  Bangladesh Medical University

  STUDY CHAIR

• Ismat Jahan Kumkum, MBBS

  Bangladesh Medical University

  PRINCIPAL INVESTIGATOR

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: February 19, 2026
• First Posted: March 16, 2026
• Study Start: August 12, 2024
• Primary Completion: December 12, 2025
• Study Completion: February 20, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)