Back to resultsD-chiro-inositol and Endometrial Thickness
Primary Purpose
Endometrial Diseases
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
DCI
Sponsored by
About this trial
This is an interventional supportive care trial for Endometrial Diseases
Eligibility Criteria
Inclusion Criteria:
- altered endometrial thickness
Exclusion Criteria:
- patients with cancer
- patients under hormonal treatments (progestogens and/or estrogens)
- patients supplemented with inositols
Sites / Locations
- ASL Umbria 2
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DCI
Arm Description
Oral supplementation with D-chiro-inositol once a day
Outcomes
Primary Outcome Measures
Change in endometrial thickness
Change in endometrial thickness by ultrasound measurement from baseline to three months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05283642
Brief Title
D-chiro-inositol and Endometrial Thickness
Official Title
The Effects of D-chiro-inositol in Endometrial Thickness
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
October 29, 2022 (Actual)
Study Completion Date
December 20, 2022 (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
Investigation of the effects of D-chiro-inositol supplementation in women with altered endometrial thickness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCI
Arm Type
Experimental
Arm Description
Oral supplementation with D-chiro-inositol once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
DCI
Intervention Description
Oral supplementation with D-chiro-inositol once daily
Primary Outcome Measure Information:
Title
Change in endometrial thickness
Description
Change in endometrial thickness by ultrasound measurement from baseline to three months
Time Frame
Two time points: baseline and after three months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- altered endometrial thickness
Exclusion Criteria:
patients with cancer
patients under hormonal treatments (progestogens and/or estrogens)
patients supplemented with inositols
Facility Information:
Facility Name
ASL Umbria 2
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
D-chiro-inositol and Endometrial Thickness
We'll reach out to this number within 24 hrs