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Extended-release vs Immediate-release Metformin in PCOS Women

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Metformin
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, metformin

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Catholic university of Sacred Heart

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Gastro intestinal disorders

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2016
Last Updated
December 6, 2016
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT02984722
Brief Title
Extended-release vs Immediate-release Metformin in PCOS Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PCOS women treated with 1500 mg/die of extended-release metformin
Arm Title
2
Arm Type
Experimental
Arm Description
PCOS women treated with 1500 mg/die of immediate-release metformin
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
Gastro intestinal disorders
Time Frame
6 months
Secondary Outcome Measure Information:
Title
number of cycles in 6 months of therapy
Time Frame
6 months
Title
insulin levels
Time Frame
6 months
Title
hirsutism score
Time Frame
6 months
Title
androstenedione levels
Time Frame
6 months
Title
testosterone levels
Time Frame
6 months
Title
free androgen index
Time Frame
6 months
Title
dheas levels
Time Frame
6 months
Title
ovarian volume
Time Frame
6 months
Title
total cholesterol
Time Frame
6 months
Title
tryglycerides levels
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Catholic university of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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Extended-release vs Immediate-release Metformin in PCOS Women

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