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A randomised study of the effect of metformin and exercise in overweight women with polycystic ovary syndrome - Metformin-exercise project

A randomised study of the effect of metformin and exercise in overweight women with polycystic ovary syndrome - Metformin-exercise project

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004257-26-DK
Enrollment
Unknown
Registered
2005-01-05
Start date
2005-02-28
Completion date
Unknown
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome is a condition characterized by obesity, anovulation and hyperandrogenism/hyperandrogenemia. Insulin resistance is common, and treatment is aimed at reducing this.

Interventions

Trade Name: Orabet Product Name: Metformin Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Sponsors

Organisation name was not entered
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Polycystic ovary syndrome, BMI 30 - 35, age 25 - 35, no hormonal treatment, no diabetes, no contraindications to metformin treatment, not pregnant or breast-feeding, no physical problems making exercise impossible. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Hormonal treatment, diabetes, contraindications to metformin treatment, pregnant or breast-feeding, physical problems making exercise impossible, liver or renal disease

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the effect of medical treatment, i.e. metformin, with the effect of exercise on insulin resistance and quality of life.;Secondary Objective: Change in hormonal and metabolic factors. ;Primary end point(s): Change in insulin resistance and quality of life

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026