MedTrace Logo

Metformin vs Inositol vs Diet vs Combination Therapy in PCOS

NCT07380841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-02-02

No results posted yet for this study

Summary

Polycystic ovary syndrome (PCOS) is a common condition that can cause irregular periods, excess male-type hormones, weight gain, and insulin resistance. This study will compare four commonly used approaches for PCOS management: metformin, inositol, a calorie-restricted diet, and a combination of all three.

A total of 192 women aged 18-35 years with PCOS (diagnosed using Rotterdam criteria) will be randomly assigned to one of four groups for 12 weeks: (A) metformin, (B) myo-inositol plus D-chiro-inositol, (C) calorie-restricted diet, or (D) combination therapy (metformin + inositol + diet). The study will assess changes in body weight, body mass index (BMI), waist circumference, fasting glucose, fasting insulin, insulin resistance (HOMA-IR), and menstrual regularity. Hormonal measures and safety outcomes will also be evaluated. The goal is to determine which approach provides the greatest overall metabolic and reproductive benefit in women with PCOS.

Conditions

Interventions

DRUG

Metformin Hydrochloride

Metformin is an insulin-sensitizing biguanide used to improve glucose metabolism and reduce insulin resistance in women with polycystic ovary syndrome. It is administered orally as part of the study protocol to evaluate its effects on metabolic, hormonal, and reproductive outcomes.

DIETARY_SUPPLEMENT

Myo-Inositol

Myo-inositol is a nutritional supplement involved in insulin signaling pathways and ovarian function. It is used in this study to assess its effect on insulin sensitivity, hormonal profile, and clinical features of polycystic ovary syndrome.

BEHAVIORAL

Dietary Restriction

A structured, supervised calorie-restricted dietary program is used as a lifestyle intervention to improve weight, metabolic parameters, and reproductive function in women with polycystic ovary syndrome.

COMBINATION_PRODUCT

Metformin + Myo-inositol + Dietary Restriction

This intervention combines pharmacological insulin sensitization and nutritional supplementation with lifestyle modification to evaluate the synergistic effect on metabolic, hormonal, and clinical outcomes in women with polycystic ovary syndrome.

Sponsors & Collaborators

  • Islamabad Medical and Dental College

    lead OTHER

Principal Investigators

  • Shemaila Saleem · Shaheed Zulfiqar Ali Bhutto Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-05-21
Primary Completion
2025-11-11
Completion
2026-01-13

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

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 NCT07380841 on ClinicalTrials.gov