NCT05678114

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 21, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

December 21, 2022

Last Update Submit

May 15, 2023

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Hyperandrogenic PCOS

EXPERIMENTAL
Dietary Supplement: Myo-inositol

Non-hyperandrogenic PCOS

EXPERIMENTAL
Dietary Supplement: Myo-inositol

Interventions

Myo-inositolDIETARY_SUPPLEMENT

Myo-inositol (4g/die)

Hyperandrogenic PCOSNon-hyperandrogenic PCOS

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with polycystic ovary syndrome
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with PCOS of any phenotype

You may not qualify if:

  • hormonal treatment (such as contraceptive pill)
  • use of supplements containing myo-inositol
  • severe co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Alma Res

Roma, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Inositol

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 10, 2023

Study Start

December 21, 2022

Primary Completion

April 28, 2023

Study Completion

May 12, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)