Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 16, 2011
CompletedFirst Posted
Study publicly available on registry
November 18, 2011
CompletedNovember 21, 2011
November 1, 2011
11 months
November 16, 2011
November 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lipid profile
The serum levels of Cholesterol, LDL, HDL and Triglyceride were measured before and after of treatment in both groups.
6 month
Secondary Outcomes (1)
Hormone levels
6 month
Study Arms (2)
Lower metformin dose group
EXPERIMENTAL500 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
ACTIVE COMPARATOR500 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Women with PCOS
You may not qualify if:
- avoiding to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hormozgan University of Medical Sciences (HUMS)
Bandarabbas, Hormozgan, 791451692, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nazanin Abdi, resident
Hormozgan University of Medical Sciences (HUMS)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
November 16, 2011
First Posted
November 18, 2011
Study Start
February 1, 2010
Primary Completion
January 1, 2011
Study Completion
February 1, 2011
Last Updated
November 21, 2011
Record last verified: 2011-11