Back to resultsEffect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Metformin
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring polycystic ovary syndrome, lipid profile, metformin
Eligibility Criteria
Inclusion Criteria:
- Women with PCOS
Exclusion Criteria:
- avoiding to participate in the study
Sites / Locations
- Hormozgan University of Medical Sciences (HUMS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lower metformin dose group
Higher metformin dose group
Arm Description
500 mg metformin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks
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
Outcomes
Primary Outcome Measures
Lipid profile
The serum levels of Cholesterol, LDL, HDL and Triglyceride were measured before and after of treatment in both groups.
Secondary Outcome Measures
Hormone levels
LH, FSH, Testosterone
Full Information
NCT ID
NCT01474967
First Posted
November 16, 2011
Last Updated
November 18, 2011
Sponsor
Hormozgan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01474967
Brief Title
Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome
Official Title
Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hormozgan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
polycystic ovary syndrome, lipid profile, metformin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lower metformin dose group
Arm Type
Experimental
Arm Description
500 mg metformin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks
Arm Title
Higher metformin dose group
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
metformex
Intervention Description
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
Intervention Name(s)
Metformin
Other Intervention Name(s)
metformex
Intervention Description
500 mg metfomin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks
Primary Outcome Measure Information:
Title
Lipid profile
Description
The serum levels of Cholesterol, LDL, HDL and Triglyceride were measured before and after of treatment in both groups.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Hormone levels
Description
LH, FSH, Testosterone
Time Frame
6 month
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with PCOS
Exclusion Criteria:
avoiding to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazanin Abdi, resident
Organizational Affiliation
Hormozgan University of Medical Sciences (HUMS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hormozgan University of Medical Sciences (HUMS)
City
Bandarabbas
State/Province
Hormozgan
ZIP/Postal Code
791451692
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome
We'll reach out to this number within 24 hrs