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Optimizing Metformin Use in Polycystic Ovary Syndrome

NCT07120815 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-08-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if a metformin dose of 1500 mg or 2250 mg per day is better to treat polycystic ovary syndrome (PCOS) in adults. It will also learn about the adverse effects of metformin. The trial aims to evaluate which metformin dose is better for:

1. improving biochemical and clinical outcomes
2. gastrointestinal side-effects
3. mental health and quality of life

Participants will:

* Be randomized to take metformin at a dose of either 1500mg or 2250mg every day for 6 months
* Visit the clinic three times during the trial for checkups and tests
* Answer questionnaires on menstrual cyclicity, mental health, quality of life and side-effects

Conditions

  • Polycystic Ovary Syndrome (PCOS)

Interventions

DRUG

Metformin 1500 mg daily

metformin 500mg tablets, 3 times per day

DRUG

Metformin 2250 mg daily

Metformin 750mg, 3 times daily

Sponsors & Collaborators

  • Valtion tutkimusraha (funding)

    collaborator UNKNOWN

  • Sakari Alhopuro foundation (funding)

    collaborator UNKNOWN

  • The Medical Society of Finland (funding)

    collaborator UNKNOWN

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Johanna M Melin, MD · The Reproductive Medicine Unit, Helsinki University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Finland

Study Locations

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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 NCT07120815 on ClinicalTrials.gov