Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome
1 other identifier
interventional
24
1 country
1
Brief Summary
Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2 Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome, gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation. In every day medical practice lower doses of Metformin are administered searching for the continuation of the treatment. However, there is no clinical study to support this assertion. The objective of this study is to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking daily doses of 1500mg and 1000mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2011
Shorter than P25 for phase_4
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
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 2, 2011
CompletedFirst Posted
Study publicly available on registry
June 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJune 6, 2011
June 1, 2011
7 months
June 2, 2011
June 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma concentration of metformin
Blood samples are collected from each patient and the plasma concentration is analysed.
First day after administration until 3 months after begining of treatment
Secondary Outcomes (1)
Number of adverse events
observation during 3 months of treatment
Study Arms (1)
Metformin
OTHERstudy parallel with one arm only.
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged between 18 and 40 years old, with no use of contraceptive drugs or insulin sensitizing agents for more than 3 months.
- PCOS diagnosis.
- Insulin resistance Index by the Homeostatic model Assessment Formula higher than 2.5.
You may not qualify if:
- Another diseases with androgen excess;
- Patients with history of serious adverse reaction or hypersensibility to any medicine;
- History or presence of renal, hepatic or gastrointestinal disorders.
- Continuous use of any pharmaco, inclusively metformin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocineselead
Study Sites (1)
Biocinese
Toledo, Paraná, 85903-590, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naura Angonese, Dr
Biocinese
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 2, 2011
First Posted
June 6, 2011
Study Start
January 1, 2011
Primary Completion
August 1, 2011
Study Completion
October 1, 2011
Last Updated
June 6, 2011
Record last verified: 2011-06