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

November 18, 2011 updated by: Hamidreza Mahboobi, Hormozgan University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Hormozgan
      • Bandarabbas, Hormozgan, Iran, Islamic Republic of, 791451692
        • Hormozgan University of Medical Sciences (HUMS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with PCOS

Exclusion Criteria:

  • avoiding to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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
Other Names:
  • metformex
Drug: Metformin
500 mg metfomin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks
Other Names:
  • metformex
Active Comparator: 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
Drug: 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
Other Names:
  • metformex
Drug: Metformin
500 mg metfomin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks
Other Names:
  • metformex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: 6 month
The serum levels of Cholesterol, LDL, HDL and Triglyceride were measured before and after of treatment in both groups.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hormone levels
Time Frame: 6 month
LH, FSH, Testosterone
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hormozgan University of Medical Sciences

Investigators

  • Principal Investigator: Nazanin Abdi, resident, Hormozgan University of Medical Sciences (HUMS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 16, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 18, 2011

Study Record Updates

Last Update Posted (Estimate)

November 21, 2011

Last Update Submitted That Met QC Criteria

November 18, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metformin in PCOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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