Inositol Treatment in Different Type of PCOS Phenotype

• Sponsor: Lo.Li.Pharma s.r.l (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05678114
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.3
• Patients Per Site Per Month: 27.9

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Dietary Supplement: Myo-inositol	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Inositol Treatment in Women With PCOS of Different Phenotype
• Actual Study Start Date: Dec 21, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Regularization of the menstrual cycle [Change from baseline number of women with irregular menstrual cycle at 4 months]

   Number of women with regular/altered menstrual cycle

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Alma Res	Roma		Italy

Sponsors and Collaborators

• Lo.Li.Pharma s.r.l

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lo.Li.Pharma s.r.l
• ClinicalTrials.gov Identifier: NCT05678114
• Other Study ID Numbers: Ins-PCOSphenotype
• First Posted: Jan 10, 2023
• Last Update Posted: Jan 10, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Inositol

Study Results

No Results Posted as of Jan 10, 2023