Optimizing Metformin Use in Polycystic Ovary Syndrome

NCT07120815 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: HUS8428/TYH20243232023-509259-15-01
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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:

• 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)

Keywords

polycystic ovary syndrome; metformin; randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• Weight

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

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

• 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)

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

• 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

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

• 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.

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

• Appearance of severe of adverse effects

  In our questionnaire the investigators will ask the participants whether they have experienced abdominal pain, reflux, nausea, diarrhoea or loss of appetite during the last two weeks and grade the symptoms from 1-5 (1 being never and 5 being all the time). The investigators will count the scores and give each participant a score between 5-25. A severe adverse effect is defined as a score of 4 or more in one of the questions (indicating a daily experience of abdominal pain, reflux, nausea, diarrhoea or loss of appetite during the last two weeks).

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

• Anti-Mullerian hormone (AMH)

  AMH will be measured in ug/l. All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting.

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

Secondary Outcomes (32)

• Body mass index (BMI)

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

• Waist circumference (WC)

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

• Waist-hip-ratio (WHR)

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

• Body adiposity index (BAI)

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

• Body composition

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

Study Arms (2)

Women 18-37 years old with a BMI ≥ 25 kg/m2, metformin 2250mg per day

ACTIVE COMPARATOR

metformin tablets 2250 mg per day

Drug: Metformin 2250 mg daily

Women 18-37 years old with a BMI ≥ 25 kg/m2, metformin 1500mg per day

EXPERIMENTAL

metformin tablets 1500 mg per day

Drug: Metformin 1500 mg daily

Interventions

Metformin 1500 mg daily DRUG

metformin 500mg tablets, 3 times per day

Women 18-37 years old with a BMI ≥ 25 kg/m2, metformin 1500mg per day

Metformin 2250 mg daily DRUG

Metformin 750mg, 3 times daily

Women 18-37 years old with a BMI ≥ 25 kg/m2, metformin 2250mg per day

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Sufficient skills in the Finnish or Swedish language

You may not qualify if:

• 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
• Untreated diabetes
• Hypothyroidism
• Hyperprolactinemia
• Use of medications for diabetes,
• Use of medications for high cholesterol
• Use of medications for obesity
• Use of medications for cortisone (per oral)
• Hypersensitivity to metformin
• Acute metabolic acidosis
• Renal impairment
• Hepatic insufficiency

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Valtion tutkimusraha (funding): collaborator
• Sakari Alhopuro foundation (funding): collaborator
• The Medical Society of Finland (funding): collaborator

Study Sites (1)

The Reproductive Medicine Unit, Helsinki University Hospital

Helsinki, Finland

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Johanna M Melin, MD

  The Reproductive Medicine Unit, Helsinki University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna M Melin, MD

CONTACT

+358505382526; johanna.melin@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, specialist in obstetrics & gynecology

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available starting 6 months after publication and remain accessible for 2 years.
• Access Criteria: Access will be granted to qualified researchers with a valid research proposal and a signed data sharing agreement. Data will be anonymized to protect participant privacy. Informed consent procedures will be reviewed to ensure participants were aware of data sharing practices.

Locations

FI (1)