Text Size

Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

This study is currently recruiting participants.
Verified June 2011 by Biocinese
Sponsor:
Information provided by:
Biocinese
ClinicalTrials.gov Identifier:
NCT01366391
First received: June 2, 2011
Last updated: June 3, 2011
Last verified: June 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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
Metformin
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366391

Contacts
Contact: Naura Angonese, Dr +55 45 2103 1900 naura.tonin@hotmail.com
Contact: Josélia Manfio, Dr +55 45 21031907 manfiojoselia@bol.com.br

Locations
Brazil
Biocinese Recruiting
Toledo, Parana, Brazil, 85903-590
Contact: Joselia Manfio, Dr     +55 45 2103 1907     manfiojoselia@bol.com.br    
Contact: Naura Angonese, Dr     +55 45 2103 1900     naura.tonin@hotmail.com    
Principal Investigator: Naura Angonese, Dr            
Sponsors and Collaborators
Biocinese
Investigators
Principal Investigator: Naura Angonese, Dr Biocinese
  More Information

No publications provided

Responsible Party: Naura Tonin Angonese, Biocinese
ClinicalTrials.gov 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
metformin
pharmacokinetic

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013