Extended-release vs Immediate-release Metformin in PCOS Women

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02984722

Metformin XR

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

1

Experimental group

Description:

PCOS women treated with 1500 mg/die of extended-release metformin

Treatment:

Drug: Metformin

2

Experimental group

Description:

PCOS women treated with 1500 mg/die of immediate-release metformin

Treatment:

Drug: Metformin