Optimizing Metformin Use in Polycystic Ovary Syndrome
ConditionPolycystic Ovary Syndrome (PCOS)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-37
SponsorHelsinki University Central Hospital
About this trial
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
Eligibility criteria
Qualifiers
Diagnosed PCOS (According to the International evidence-based Guideline for PCOS 2023)
Age: 18-37 years
BMI: ≥ 25 and <40 kg/m2
Signed informed consent and willingness to comply with the trial procedures
Disqualifiers
Not meeting the criteria according to the International evidence-based Guideline for PCOS 2023)
Use of hormonal contraceptive during the last 3 months
Pregnancy
Breastfeeding
Trial design
Treatments tested in this trial
- Metformin 1500 mg daily
- Metformin 2250 mg daily
Treatment groups
184 Participants
are divided into 2 treatment groupsSponsors and collaborators
Helsinki University Central Hospital
Lead sponsor
Valtion tutkimusraha (funding)
Collaborator
Sakari Alhopuro foundation (funding)
Collaborator
The Medical Society of Finland (funding)
Collaborator
Source ClinicalTrials.gov