Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Metformin 1500 mg daily

    Drug

    metformin 500mg tablets, 3 times per day

  • Metformin 2250 mg daily

    Drug

    Metformin 750mg, 3 times daily

Treatment groups

184 Participants
are divided into 2 treatment groups
Group A: Women 18-37 years old with a BMI ≥ 25 kg/m2, metformin 2250mg per dayActive comparator 1 intervention
Group B: Women 18-37 years old with a BMI ≥ 25 kg/m2, metformin 1500mg per dayExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weight

Weight will be measured by a standard scale to an accuracy of +/- 0,1kg.

Time frame
The investigators will measure change in outcomes from baseline to 14 and 26 weeks
2

Homeostatic model assessment for insulin resistance (HOMA-IR)

HOMA-IR will be calculated with the formula: fasting plasma glucose (mmol/L) × fasting serum insulin (mU/L) divided by 22.5 (9)

Time frame
The investigators will measure change in outcomes from baseline to 14 and 26 weeks
3

Hirsutism

Modified Ferriman Gallwey score (mFG) will be measured and a score of 4 or more will be regarded as hirsutism in Caucasian women, whereas a score of 6 or more will be regarded hirsutism for other ethnicities

Time frame
The investigators will report change from baseline to 14 and 26 weeks.
4

Total testosterone

Testosterone nmol/l (liquid chromatography with tandem mass spectrometry (LC-MS/MS). All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting.

Time frame
The investigators will measure change from baseline to 14 and 26 weeks

Secondary outcomes

1

Body mass index (BMI)

Weight (kilogram) and height (metre) will be combined to report BMI in kg/m\^2

Time frame
The investigators will measure change in outcomes from baseline to 14 and 26 weeks
2

Waist circumference (WC)

WC will be measured halfway between the participant's lowest rib and the top of the participant's hipbone

Time frame
The investigators will measure change in outcomes from baseline to 14 and 26 weeks
3

Waist-hip-ratio (WHR)

WHR will be calculated as waist measurement divided by hip measurement (W⁄H). Hip circumference is determined as the maximum value over the glottal region, measured to the nearest centimetre.

Time frame
The investigators will measure change in outcomes from baseline to 14 and 26 weeks
4

Body adiposity index (BAI)

BAI will be measured using the following equation: hip circumference (cm)/height (m) - 18

Time frame
The investigators will measure change in outcomes from baseline to 14 and 26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: