Inositol Treatment in Different Type of PCOS Phenotype

May 15, 2023 updated by: Lo.Li.Pharma s.r.l

The Effect of Inositol Treatment in Women With PCOS of Different Phenotype

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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
      • Roma, Italy
        • Clinica Alma Res

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 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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 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: Hyperandrogenic PCOS
Dietary supplement: Myo-inositol
Myo-inositol (4g/die)
Experimental: Non-hyperandrogenic PCOS
Dietary supplement: Myo-inositol
Myo-inositol (4g/die)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regularization of the menstrual cycle
Time Frame: Change from baseline number of women with irregular menstrual cycle at 4 months
Number of women with regular/altered menstrual cycle
Change from baseline number of women with irregular menstrual cycle at 4 months

Collaborators and Investigators

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

Sponsor

Lo.Li.Pharma s.r.l

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 (Actual)

December 21, 2022

Primary Completion (Actual)

April 28, 2023

Study Completion (Actual)

May 12, 2023

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ins-PCOSphenotype

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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