D-chiro-inositol and Endometrial Thickness

Sponsor

Lo.Li.Pharma s.r.l (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05283642

Collaborator

(none)

Enrollment

Location

Arm

6.8

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endometrial Diseases	Dietary Supplement: DCI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effects of D-chiro-inositol in Endometrial Thickness

Actual Study Start Date :

Mar 8, 2022

Anticipated Primary Completion Date :

Jul 29, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DCI Oral supplementation with D-chiro-inositol once a day	Dietary Supplement: DCI Oral supplementation with D-chiro-inositol once daily

Arm

Intervention/Treatment

Experimental: DCI

Oral supplementation with D-chiro-inositol once a day

Dietary Supplement: DCI

Oral supplementation with D-chiro-inositol once daily

Outcome Measures

Primary Outcome Measures

Change in endometrial thickness [Two time points: baseline and after three months]
Change in endometrial thickness by ultrasound measurement from baseline to three months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

altered endometrial thickness

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ASL Umbria 2	Terni	Umbria	Italy	05100

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:

NCT05283642

Other Study ID Numbers:

DCI_GYN22

First Posted:

Mar 17, 2022

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Diseases

Study Results

No Results Posted as of Mar 17, 2022