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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hamidreza Mahboobi, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01474967
First received: November 16, 2011
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
 Drug: Metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • Lipid profile [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    The serum levels of Cholesterol, LDL, HDL and Triglyceride were measured before and after of treatment in both groups.


Secondary Outcome Measures:
  • Hormone levels [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    LH, FSH, Testosterone


Enrollment: 50
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 metfomin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks
Other Name: 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 Name: metformex

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with PCOS

Exclusion Criteria:

  • avoiding to participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474967

Locations
Iran, Islamic Republic of
Hormozgan University of Medical Sciences (HUMS)
Bandarabbas, Hormozgan, Iran, Islamic Republic of, 791451692
Sponsors and Collaborators
Hormozgan University of Medical Sciences
Investigators
Principal Investigator: Nazanin Abdi, resident Hormozgan University of Medical Sciences (HUMS)
  More Information

No publications provided

Responsible Party: Hamidreza Mahboobi, Resident, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01474967     History of Changes
Other Study ID Numbers: Metformin in PCOS
Study First Received: November 16, 2011
Last Updated: November 18, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Hormozgan University of Medical Sciences:
polycystic ovary syndrome
lipid profile
metformin

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013