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Optimizing metformin use in polycystic ovary syndrome - A randomized controlled trial
EU CTIS ID: 2023-509259-15-01
What this study is testing
To find out if a metformin dose of 1500mg is inferior to 2250 mg per day regarding biochemical and clinical outcomes in overweight individuals 18-37 years of age with PCOS.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women aged 18-37 years of age
- A diagnosis of PCOS according to the updated 2023 International PCOS guideline
- BMI ≥ 25 kg/m2 and <40 kg/m2
- Signed informed consent and willingness to comply with the trial procedures
You likely can't join if
- Females not meeting the 2003 Rotterdam criteria for PCOS
- Investigator site staff directly involved in the conduct of the study and their family members
- Females with hormonal contraceptive during the last 3 months
- Women that are pregnant or breastfeeding
- Females with an untreated diabetes, hypothyroidism or hyperprolactinemia
- Use of medications for diabetes, high cholesterol, obesity and cortisone (per oral)
See the full eligibility criteria
- Women aged 18-37 years of age
- A diagnosis of PCOS according to the updated 2023 International PCOS guideline
- BMI ≥ 25 kg/m2 and <40 kg/m2
- Signed informed consent and willingness to comply with the trial procedures
- Females not meeting the 2003 Rotterdam criteria for PCOS
- Investigator site staff directly involved in the conduct of the study and their family members
- Females with hormonal contraceptive during the last 3 months
- Women that are pregnant or breastfeeding
- Females with an untreated diabetes, hypothyroidism or hyperprolactinemia
- Use of medications for diabetes, high cholesterol, obesity and cortisone (per oral)
- Serious mental illness
- Females with contraindication for use of metformin (hypersensitivity to metformin, acute metabolic acidosis, severe renal failure, hepatic insufficiency, heart- or respiratory failure)
- Alcoholism
- A planned surgical intervention during the next 26 weeks
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.