Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01366391
• Other study ID #: 0038.0 208.00-09
• Status: Recruiting
• Phase: Phase 4
• First received: June 2, 2011
• Last updated: June 3, 2011
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: June 2011
• Source: Biocinese
• Contact: Naura Angonese, Dr
• Phone: +55 45 2103 1900
• Email: naura.tonin[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
Metformin 500 mg tablet (1000 or 1500 mg/day)

Locations

Country	Name	City	State
Brazil	Biocinese	Toledo	Parana

Sponsors (1)

Lead Sponsor	Collaborator
Biocinese

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of adverse events	All adverse events are registered during the treatment	observation during 3 months of treatment	No