NCT05283642

Brief Summary

Investigation of the effects of D-chiro-inositol supplementation in women with altered endometrial thickness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 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

March 8, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

December 23, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

March 8, 2022

Last Update Submit

December 22, 2022

Conditions

Endometrial Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in endometrial thickness

    Change in endometrial thickness by ultrasound measurement from baseline to three months

    Two time points: baseline and after three months

Study Arms (1)

DCI

EXPERIMENTAL

Oral supplementation with D-chiro-inositol once a day

Dietary Supplement: DCI

Interventions

DCIDIETARY_SUPPLEMENT

Oral supplementation with D-chiro-inositol once daily

DCI

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- altered endometrial thickness

You may not qualify if:

  • patients with cancer
  • patients under hormonal treatments (progestogens and/or estrogens)
  • patients supplemented with inositols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASL Umbria 2

Terni, Umbria, 05100, Italy

Location

MeSH Terms

Conditions

Uterine Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 17, 2022

Study Start

March 8, 2022

Primary Completion

October 29, 2022

Study Completion

December 20, 2022

Last Updated

December 23, 2022

Record last verified: 2022-03

Locations

IT(1)