Metformin Versus Acarbose Treatment in Infertile Overweight Women With Polycystic Ovary Syndrome (PCOS)
Metformin vs. Acarbose Treatment in Infertile Overweight Women With PCOS: A Prospective Randomized Clinical Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
This study is a prospective randomized clinical trial to compare the endocrine and metabolic effects of two anti diabetic drugs (metformin vs. acarbose) in infertile overweight women with PCOS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 17, 2011
CompletedFirst Posted
Study publicly available on registry
January 19, 2011
CompletedJanuary 6, 2012
August 1, 2006
2 years
January 17, 2011
January 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight reduction (BMI improvement)
compare the effect of Metformin and Acarbose to weight reduction
After 3 months of Metformin or Acarbose
Secondary Outcomes (10)
Fasting blood sugar (FBS)
two hours post prandial blood sugar
FSH
6 months
LH
6 months
Estradiol
6 months
Prolactin
6 months
- +5 more secondary outcomes
Study Arms (2)
Metformin reciepiants
EXPERIMENTALInfertile overweight women with PCO who received Metformin
Acarbose reciepiants
EXPERIMENTALInfertile overweight women with PCO who received Acarbose
Interventions
The metformin dose will be 500 mg/ day in the first week, 1000 mg/ day in the second week and 1500 mg/ day for the next 10 weeks.
Acarbose group will be treated by acarbose (its dose will be 100 mg/day in the first week, 200 mg/ day in the second week and 300 mg/ day for the next 10 weeks).
Eligibility Criteria
You may qualify if:
- Poly Cystic Ovarian Syndrome patients
- Age \< 40 years
- BMI \> 25 kg/m2
You may not qualify if:
- Smoking
- Overt diabetes mellitus, hyperprolactinemia, diseases that would disturb clinical and hormonal responses (adrenal disease or tumors, ovarian tumors, thyroid disease)
- The use of hormonal medications or drugs that might interfere with carbohydrate metabolism over the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, Iran
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ashraf Moini, MD
Scientific board
- STUDY DIRECTOR
Elham Amirchaghmaghi, MD
Invetigator
- PRINCIPAL INVESTIGATOR
Zhila Ahmadi, BS.c
Investigator
- PRINCIPAL INVESTIGATOR
Bita Eslami, MPH
Investigator
- PRINCIPAL INVESTIGATOR
Ali asghar Akhlaghi, BS.c
Investigator
- PRINCIPAL INVESTIGATOR
Reza salmanyazdi, MLD
Investigator
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2011
First Posted
January 19, 2011
Study Start
December 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 6, 2012
Record last verified: 2006-08