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Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

NCT00317928 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2006-10-11

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Metformin

Sponsors & Collaborators

  • Regional Hospital Holstebro

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Aarhus University Hospital Skejby

    lead OTHER

Principal Investigators

  • Ditte Trolle, MD · Skejby University Hospital, Aarhus, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Completion
2004-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00317928 on ClinicalTrials.gov