Extended-release vs Immediate-release Metformin in PCOS Women

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02984722
• Other study ID #: Metformin XR
• Status: Not yet recruiting
• Phase: N/A
• First received: December 3, 2016
• Last updated: December 6, 2016
• Start date: December 2016

Study information

• Verified date: December 2016
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Catholic University of Sacred Heart
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria:

• pregnancy

• diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)

• past history of cardiovascular diseases

• past history of gastro-intestinal diseases

• significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or adrenal);

• neoplasms.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Metformin

Locations

Country	Name	City	State
Italy	Catholic university of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastro intestinal disorders		6 months	No
Secondary	number of cycles in 6 months of therapy		6 months	Yes
Secondary	insulin levels		6 months	No
Secondary	hirsutism score		6 months	No
Secondary	androstenedione levels		6 months	No
Secondary	testosterone levels		6 months	No
Secondary	free androgen index		6 months	No
Secondary	dheas levels		6 months	No
Secondary	ovarian volume		6 months	No
Secondary	total cholesterol		6 months	No
Secondary	tryglycerides levels		6 months	No