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D-chiro-inositol and Endometrial Thickness

Primary Purpose

Endometrial Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
DCI
Sponsored by
Lo.Li.Pharma s.r.l
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometrial Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
March 8, 2022
Last Updated
December 22, 2022
Sponsor
Lo.Li.Pharma s.r.l
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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

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D-chiro-inositol and Endometrial Thickness

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