Trial With Metformin in Women With Polycystic Ovary Syndrome

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2002-12-31

Brief Summary

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The investigators wanted to elucidate the effects of metformin in Polycystic Ovary Syndrome (PCOS) by performing a randomized, double-blinded, placebo-controlled cross-over study.

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Detailed Description

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Eligible women who gave written informed consent were assigned to 6 months of treatment with either 850 mg of metformin or placebo twice daily, followed by a wash-out period of 3 months before cross-over to the alternate treatment for another 6 months. Randomization defining treatment sequence was done at inclusion by random number tables. The appearance of the tablets was identical, and patients and investigators were blinded to treatment allocation. The randomization code was stored in a closed envelope until all participants had finished the treatment. Participants were seen by one of the investigators before inclusion and every second month during treatment periods, always in the morning after an overnight fast of at least 8 h. They were weighed wearing light clothing. Waist circumference was measured at the umbilical level and hip circumference at the trochanter region. Systolic and diastolic blood pressure was measured with a semiautomatic blood pressure monitor and a blood sample was drawn for immediate analysis without respect to bleeding periods. All participants registered their bleeding periods in a calendar during both study periods and the 3 months wash-out period. Calculation of sample size was based on the assumption that at least 50% of the women would experience at least 30% more menstrual periods on metformin than on placebo. Based on a power of 90 (b = 0.10) to detect a significant difference \[two-sided P-value of 0.05\], the minimum sampling size was calculated to 44 subjects.

We also assumed a 10% drop-out rate, and thus aimed at including 50 women. As drop-out rate quickly rose higher than expected, we decided to include 60 women. In the intention-to-treat analysis, the values of each participant after 6 months of metformin or placebo were compared with the baseline values. Linear regression analysis with the changes in testosterone and homeostasis model assessment (HOMA) index as dependent variables was performed to examine potential relations between the changes. The per protocol analysis included data from participants completing both study periods, i.e. the difference between the values of each participant after placebo and metformin, respectively, was calculated, and a significance test performed on the differences.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Metformin

Metformin 850 mg x 2 in six months

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin 1500 mg (=2 pills) per day in six months

Placebo

Placebo 2 tablets daily for six months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 pills per day in six months; pills look like metformin pills

Interventions

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Metformin

Metformin 1500 mg (=2 pills) per day in six months

Intervention Type DRUG

Placebo

2 pills per day in six months; pills look like metformin pills

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* testosterone value above the upper normal limit and
* oligo- or amenorrhea,

Exclusion Criteria

* periclimacteric gonadotrophin values,
* hyperprolactinaemia,
* diabetes mellitus,
* impaired thyroid,
* renal or hepatic function,
* hormonal treatment,
* pregnancy,
* lactation or a wish for fertility treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No