Extended-release vs Immediate-release Metformin in PCOS Women

December 6, 2016 updated by: Rosanna Apa, Catholic University of the Sacred Heart
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Catholic University Of Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
PCOS women treated with 1500 mg/die of extended-release metformin
Drug: Metformin
Experimental: 2
PCOS women treated with 1500 mg/die of immediate-release metformin
Drug: Metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gastro intestinal disorders
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
total cholesterol
Time Frame: 6 months
6 months
androstenedione levels
Time Frame: 6 months
6 months
testosterone levels
Time Frame: 6 months
6 months
free androgen index
Time Frame: 6 months
6 months
tryglycerides levels
Time Frame: 6 months
6 months
insulin levels
Time Frame: 6 months
6 months
number of cycles in 6 months of therapy
Time Frame: 6 months
6 months
hirsutism score
Time Frame: 6 months
6 months
dheas levels
Time Frame: 6 months
6 months
ovarian volume
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 3, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metformin XR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

Clinical Trials on Metformin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe