Back to resultsInositol Treatment in Different Type of PCOS Phenotype
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Myo-inositol
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria: women with PCOS of any phenotype Exclusion Criteria: hormonal treatment (such as contraceptive pill) use of supplements containing myo-inositol severe co-morbidities
Sites / Locations
- Clinica Alma Res
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hyperandrogenic PCOS
Non-hyperandrogenic PCOS
Arm Description
Outcomes
Primary Outcome Measures
Regularization of the menstrual cycle
Number of women with regular/altered menstrual cycle
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05678114
Brief Title
Inositol Treatment in Different Type of PCOS Phenotype
Official Title
The Effect of Inositol Treatment in Women With PCOS of Different Phenotype
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
May 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperandrogenic PCOS
Arm Type
Experimental
Arm Title
Non-hyperandrogenic PCOS
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Myo-inositol
Intervention Description
Myo-inositol (4g/die)
Primary Outcome Measure Information:
Title
Regularization of the menstrual cycle
Description
Number of women with regular/altered menstrual cycle
Time Frame
Change from baseline number of women with irregular menstrual cycle at 4 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with polycystic ovary syndrome
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with PCOS of any phenotype
Exclusion Criteria:
hormonal treatment (such as contraceptive pill)
use of supplements containing myo-inositol
severe co-morbidities
Facility Information:
Facility Name
Clinica Alma Res
City
Roma
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Inositol Treatment in Different Type of PCOS Phenotype
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