Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00317928

Enrollment

Registered

2006-04-25

Start date

2001-08-31

Completion date

2004-09-30

Last updated

2006-10-11

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

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome, Metformin, Metabolic Syndrome, Hyperandrogenism, Ovulation

Brief summary

Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular. Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment.

Interventions

DRUGMetformin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of PCOS * Age 20 - 45

Exclusion criteria

Diabetes * Diabetes * Hormonal treatment * Pregnancy, lactation * Periclimacteric

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026