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

November 16, 2011
November 18, 2011
February 2010
January 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01474967 on ClinicalTrials.gov Archive Site
Hormone levels [ Time Frame: 6 month ] [ Designated as safety issue: No ]
LH, FSH, Testosterone
Same as current
Not Provided
Not Provided
 
Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome
Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • 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
  • 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
  • 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
    Intervention: Drug: Metformin
  • 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
    Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with PCOS

Exclusion Criteria:

  • avoiding to participate in the study
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01474967
Metformin in PCOS
Yes
Hamidreza Mahboobi, Hormozgan University of Medical Sciences
Hormozgan University of Medical Sciences
Not Provided
Principal Investigator: Nazanin Abdi, resident Hormozgan University of Medical Sciences (HUMS)
Hormozgan University of Medical Sciences
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP