Back to resultsCombination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone
Primary Purpose
Polycystic Ovary Syndrome, Hirsutism, Menstrual Irregularity
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
myo-inositol 1500 gr
myo-inositol 2000 gr + folic acid 200 mcg
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring myo-inositol, folic acid
Eligibility Criteria
Inclusion Criteria:
- women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003
- BMI > 25 kg/m2
- age 18-35 years
Exclusion Criteria:
- pregnancy
- significant liver or renal impairment
- other hormonal dysfunctions (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
- neoplasms
- unstable mental illness
- diagnosis of diabetes mellitus or impaired glucose tolerance
- use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior entering the study.
Sites / Locations
- Catholic University of Sacred Heart
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
myo-inositol 1500 gr
myo-inositol 2000gr + folic acid 200 mcg
Arm Description
6 months treatment with myo-inositol 1500 gr
Outcomes
Primary Outcome Measures
number of cycles in six months of therapy
We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.
Secondary Outcome Measures
effects on oral glucose tollerance test
effects on hoormonal assay
effects oon lipide profile
Full Information
NCT ID
NCT01555190
First Posted
March 13, 2012
Last Updated
July 22, 2020
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT01555190
Brief Title
Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone
Official Title
Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
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
Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Hirsutism, Menstrual Irregularity
Keywords
myo-inositol, folic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
myo-inositol 1500 gr
Arm Type
Active Comparator
Arm Description
6 months treatment with myo-inositol 1500 gr
Arm Title
myo-inositol 2000gr + folic acid 200 mcg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
myo-inositol 1500 gr
Intervention Type
Drug
Intervention Name(s)
myo-inositol 2000 gr + folic acid 200 mcg
Primary Outcome Measure Information:
Title
number of cycles in six months of therapy
Description
We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
effects on oral glucose tollerance test
Time Frame
six months
Title
effects on hoormonal assay
Time Frame
6 months
Title
effects oon lipide profile
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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003
BMI > 25 kg/m2
age 18-35 years
Exclusion Criteria:
pregnancy
significant liver or renal impairment
other hormonal dysfunctions (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
neoplasms
unstable mental illness
diagnosis of diabetes mellitus or impaired glucose tolerance
use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior entering the study.
Facility Information:
Facility Name
Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone
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