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Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome

NCT ID: NCT01474967

Last Updated: 2011-11-21

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

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-02-28

Brief Summary

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Polycystic ovarian syndrome (PCOS) is the most common cause of anovulatory infertility and causes menstrual disruption in 6.6-6.8% of women in reproductive age and is characterized by insulin resistance, hyperinsulinemia, hyperandrogenism and anovulation. The gaol of this study was to assess the effects of metformin on menstrual disorders and lipid profile in women with PCOS in bandarabbas.

Detailed Description

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Poly cystic ovarian syndrome (PCOS) is a common hormonal disorder in women that affecting of 6.6-6.8% of women o f reproductive age. PCOS associated with a broad range of clinical, hormonal and metabolic disorders consist of hirsutism, Obesity, Acne and elevated male hormones, anovulatory cycles, dyslipidemia and infertility.

Metformin is an oral hyperglycemic agent witch by decrease insulin resistance and improving serum glucose level in diabetic patients and anovulatory cyle in women with PCOS. The goal of this study is to evaluate the efficacy of different dosage of metformin on menstruation and lipid profile in women with PCOS in banda-abbas.

Conditions

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Polycystic Ovary Syndrome

Keywords

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polycystic ovary syndrome lipid profile metformin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lower metformin dose group

500 mg metformin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

500 mg metfomin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks

Higher metformin dose group

500 mg metfomin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 1 week 500 mg metformin with breakfast and 1000 mg with dinner for 22 weeks

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

500 mg metformin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 1 week 500 mg metformin with breakfast and 1000 mg with dinner for 22 weeks

Interventions

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Metformin

500 mg metformin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 1 week 500 mg metformin with breakfast and 1000 mg with dinner for 22 weeks

Intervention Type DRUG

Metformin

500 mg metfomin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks

Intervention Type DRUG

Other Intervention Names

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metformex metformex

Eligibility Criteria

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Inclusion Criteria

* Women with PCOS

Exclusion Criteria

* avoiding to participate in the study
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Mahboobi

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nazanin Abdi, resident

Role: PRINCIPAL_INVESTIGATOR

Hormozgan University of Medical Sciences (HUMS)

Locations

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Hormozgan University of Medical Sciences (HUMS)

Bandarabbas, Hormozgan, Iran

Site Status

Countries

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Iran

Other Identifiers

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Metformin in PCOS

Identifier Type: -

Identifier Source: org_study_id