Extended-release vs Immediate-release Metformin in PCOS Women

Catholic University of the Sacred Heart80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

Catholic university of Sacred Heart

Rome, Rome, Italy

Outcomes

Primary Outcomes

Gastro intestinal disorders

Time frame: 6 months

Secondary Outcomes

number of cycles in 6 months of therapy

Time frame: 6 months

insulin levels

Time frame: 6 months

hirsutism score

Time frame: 6 months

androstenedione levels

Time frame: 6 months

testosterone levels

Time frame: 6 months

free androgen index

Time frame: 6 months

dheas levels

Time frame: 6 months

ovarian volume

Time frame: 6 months

total cholesterol

Time frame: 6 months

tryglycerides levels

Time frame: 6 months

Data from ClinicalTrials.gov

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