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Extended-release vs Immediate-release Metformin in PCOS Women

NCT ID: NCT02984722

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Keywords

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PCOS metformin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

2

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Rosanna Apa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic university of Sacred Heart

Rome, Rome, Italy

Site Status

Countries

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Italy

Other Identifiers

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Metformin XR

Identifier Type: -

Identifier Source: org_study_id