Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2004-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Keywords

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Polycystic Ovary Syndrome Metformin Metabolic Syndrome Hyperandrogenism Ovulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of PCOS
* Age 20 - 45

Exclusion Criteria

* Diabetes
* Hormonal treatment
* Pregnancy, lactation
* Periclimacteric

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Ditte Trolle, MD

Role: PRINCIPAL_INVESTIGATOR

Skejby University Hospital, Aarhus, Denmark

Other Identifiers

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160350-1

Identifier Type: -

Identifier Source: org_study_id