Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Biocinese.
Recruitment status was  Recruiting
Information provided by:
Biocinese Identifier:
First received: June 2, 2011
Last updated: June 3, 2011
Last verified: June 2011

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.

Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Resource links provided by NLM:

Further study details as provided by Biocinese:

Primary Outcome Measures:
  • Plasma concentration of metformin [ Time Frame: First day after administration until 3 months after begining of treatment ] [ Designated as safety issue: No ]
    Blood samples are collected from each patient and the plasma concentration is analysed.

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: observation during 3 months of treatment ] [ Designated as safety issue: No ]
    All adverse events are registered during the treatment

Estimated Enrollment: 24
Study Start Date: January 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
study parallel with one arm only.
Drug: Metformin
Metformin 500 mg tablet (1000 or 1500 mg/day)
Other Name: Glifage 500 mg

Detailed Description:
Patients with PCOS diagnosis and that are able to attempt the inclusion criteria are divided in two groups: administration of metformin 500 mg tablet three times/day as well 1500 mg/day (group A)and administration of metformin 500 mg tablet twice/day or 1000 mg/day (group B). Blood samples were collected to the pharmacokinetic evaluation from first day of administration until 3 months after beginning of treatment. The patients are monitored during 3 months and all side effects are register. The efficacy of both treatment are analyzed by biochemical and physical evaluation.

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01366391

Contact: Naura Angonese, Dr +55 45 2103 1900
Contact: Josélia Manfio, Dr +55 45 21031907

Biocinese Recruiting
Toledo, Parana, Brazil, 85903-590
Contact: Joselia Manfio, Dr    +55 45 2103 1907   
Contact: Naura Angonese, Dr    +55 45 2103 1900   
Principal Investigator: Naura Angonese, Dr         
Sponsors and Collaborators
Principal Investigator: Naura Angonese, Dr Biocinese
  More Information

No publications provided

Responsible Party: Naura Tonin Angonese, Biocinese Identifier: NCT01366391     History of Changes
Other Study ID Numbers: 0038.0 208.00-09
Study First Received: June 2, 2011
Last Updated: June 3, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Biocinese:
polycystic ovary syndrome

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2015