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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin

• Registration Number: NCT01474967
• Lead Sponsor: Hormozgan University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Status Verified: 2011-11
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-18
• Last Update Submitted: 2011-11-18
• Last Update Posted: 2011-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Women with PCOS

Exclusion Criteria

• avoiding to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower metformin dose group	Metformin	500 mg metformin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks
Higher metformin dose group	Metformin	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

Primary Outcome Measures

Name	Time	Method
Lipid profile	6 month	The serum levels of Cholesterol, LDL, HDL and Triglyceride were measured before and after of treatment in both groups.

Secondary Outcome Measures

Name	Time	Method
Hormone levels	6 month	LH, FSH, Testosterone

Trial Locations

Locations (1)

Hormozgan University of Medical Sciences (HUMS); 🇮🇷 Bandarabbas, Hormozgan, Iran, Islamic Republic of