Working… Menu

Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01366391
Recruitment Status : Unknown
Verified June 2011 by Biocinese.
Recruitment status was:  Recruiting
First Posted : June 6, 2011
Last Update Posted : June 6, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome
Study Start Date : January 2011
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
study parallel with one arm only.
Drug: Metformin
Metformin 500 mg tablet (1000 or 1500 mg/day)
Other Name: Glifage 500 mg

Primary Outcome Measures :
  1. Plasma concentration of metformin [ Time Frame: First day after administration until 3 months after begining of treatment ]
    Blood samples are collected from each patient and the plasma concentration is analysed.

Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: observation during 3 months of treatment ]
    All adverse events are registered during the treatment

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01366391

Layout table for location contacts
Contact: Naura Angonese, Dr +55 45 2103 1900
Contact: Josélia Manfio, Dr +55 45 21031907

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Naura Angonese, Dr Biocinese

Layout table for additonal information
Responsible Party: Naura Tonin Angonese, Biocinese Identifier: NCT01366391     History of Changes
Other Study ID Numbers: 0038.0 208.00-09
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: June 6, 2011
Last Verified: June 2011
Keywords provided by Biocinese:
polycystic ovary syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs