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NCT05678114 Clinical Trial

Inositol Treatment in Different Type of PCOS Phenotype

Polycystic Ovary Syndrome Clinical Trial

Official title:
The Effect of Inositol Treatment in Women With PCOS of Different Phenotype

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05678114
Other study ID # Ins-PCOSphenotype
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 21, 2022
Est. completion date May 12, 2023

Study information
Verified date May 2023
Source Lo.Li.Pharma s.r.l
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria)

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date May 12, 2023
Est. primary completion date April 28, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Myo-inositol
Myo-inositol (4g/die)

Locations
Country Name City State
Italy Clinica Alma Res Roma

Sponsors (1)
Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Regularization of the menstrual cycle Number of women with regular/altered menstrual cycle Change from baseline number of women with irregular menstrual cycle at 4 months
See also
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