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Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome

NCT03117517 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2020-03-02

Study results available
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Summary

Objective:

1. To investigate the changes in the levels of interleukin-6 and interleukin-8 after 3 months treatment with metformin alone and combination of metformin and pioglitazone in patients with polycystic ovarian syndrome (PCOS).
2. To evaluate insulin resistance in all the groups at baseline and after 3 months of treatment.

Design: Two-Arm Randomized Clinical trial.

Setting: Out-Patient Department (OPD) of Mardan Medical Complex, Khyber Medical University.

Patient(s): One hundred and two patients with PCOS.

Intervention(s): 51 women will receive metformin according to the body weight with maximum dose of 1000 mg (BD) daily. Remaining 51 will receive metformin and pioglitazone combination according to the body weight with maximum dose of 1000 mg and 30 mg (BD) daily.

Main outcomes measure(s): Serum concentrations of fasting blood glucose, insulin, homeostatic model assessment for insulin resistance (HOMA-IR), follicle stimulating hormone (FSH), luteinizing hormone (LH), interleukin-6 (IL-6) and i-nterleukin-8 (IL-8).

Conditions

  • Polycystic Ovarian Syndrome

Interventions

DRUG

Metformin

Metformin (1000 mg)

DRUG

Metformin, Pioglitazone

Metformin (1000 mg) Pioglitazone (30 mg)

Sponsors & Collaborators

  • Khyber Medical University Peshawar

    lead OTHER

Principal Investigators

  • Mohsin Shah, PhD · Institute oF Basic Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2017-08-29
Completion
2018-03-07

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03117517 on ClinicalTrials.gov