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NCT05448365 Clinical Trial

Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

Uterine Fibroids Clinical Trial

Official title:
The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05448365
Other study ID # DELPHYS PLUS
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 1, 2022
Est. completion date October 1, 2025

Study information
Verified date February 2024
Source Lo.Li.Pharma s.r.l
Contact Massimo Stomati, Ph. D
Phone 0831851303
Email mstomati@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date October 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 40 Years
Eligibility Inclusion Criteria: 1. uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids 2. eligible for surgery 3. symptoms like menometrorrhagia or pelvic pain Exclusion Criteria: 1. BMI>30 2. currently pregnant or breastfeeding 3. diabetic 4. suspect of malignancy 5. diagnosis of cancer

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol
The patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25µg Vitamin D
• Placebo
Maltodextrines

Locations
Country Name City State
Italy Ospedale Dario camberlingo Francavilla Fontana Puglia
Italy Ospedale Veris Delli Ponti Scorrano Puglia

Sponsors (1)
Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diameter Greater diameter of the diagnosed uterine fibroids 3 months
Secondary Volume Total volume of the diagnosed uterine fibroids 3 months
Secondary Need for surgery The percentage of patients that decide to avoid surgery 3 months
Secondary pVEGF-R the phosphorilation of VEGF receptor 3 months
Secondary Marker of cellular proliferation expression of ki67, ER, PR 3 months
See also
  Status Clinical Trial Phase
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Completed NCT00958334 - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Phase 2
Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A