Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

Sponsor
Beni-Suef University
Study ID
NCT05965908
Phase
PHASE3
Status
Completed

Conditions

  • Polycystic Ovary

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    glucagon-like peptide 1 receptor agonist
  • Metformin — DRUG
    biguanide antihyperglycemic

Study Details

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.

Key Dates

First listed
Jul 28, 2023
Start date
Aug 1, 2024
Status verified
Aug 2026
Primary completion
Nov 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
183 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: liraglutide
    will receive the drug via daily subcutaneous injection to ensure optimal tolerability, the dose was titrated upward weekly by increments of 0.6 mg (i.e., 1.2 mg/day in week 2, 1.8 mg/day in week 3, 2.4 mg/day in week 4) until reaching the target therapeutic dose of 3.0 mg/day for 6-month study duration.
  • Active Comparator: metformin
    the patient is given Glucophage 1000 mg tab once daily after lunch for 6 months
  • No Intervention: control
    not given any drug

Primary Outcome Measure

Insulin Resistance (HOMA-IR) [ Time Frame: 6-months ]

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