Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05918848
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-26
First Post:
2023-05-11
Brief Title:
Tocopherol Acetate Vaginal Administration in Pre-peri and Postmenopausal Women
Sponsor:
Gemelli Molise Hospital
Organization:
Gemelli Molise Hospital
Study Overview
Official Title:
Performance and Safety of Vaginal Administration of Tocopherol Acetate Vitamin E in Pre- Peri and Postmenopausal Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this non-controlled Investigator Initiated Trail IIT with a retrospective design is to evaluate the performance and safety of the vaginal administration of tocopherol acetate vitamin E in pre-peri and postmenopausal women The main objectives of the study will be the evaluation of the vaginal pH of the vaginal eubiosis improving the lactobacilli flora and microbiota and of sign and symptoms of women The patients were visited at baseline with the collection of vaginal swabs and treated with vaginal administration of tocopherol acetate for 14 days At the end of treatment final visit the patients were visited with the collection of vaginal swabs
Detailed Description:
The vaginal microbiota has a significant bearing on a womans mental and physical health at every stage of life A balanced microflora of the vaginal environment eubiosis consists of a predominant presence of lactic acid bacteria Lactobacilli ensure the maintenance of an acidic pH that effectively makes the environment inhospitable to pathogens by preventing infection and protecting the genital tract At the end of the reproductive period the reduction of sex hormones particularly estrogen results in a decrease in the lactobacillus component with consequent depletion of the vaginal microbiota and increased susceptibility to pathogens Tocopherol vitamin E is an essential human nutrient found mainly in oily fruits It is a fat-soluble molecule with high antioxidant power Topically administered it not only plays a key role in protecting epithelial cell membranes from oxidative damage but is also able to modulate bacterial growth by contributing to pH acidification The latter feature in the vaginal canal creates a favorable environment for the lactobacilli flora positively affecting the microbial population and thus contributing to the prevention of all those problems related to increased vaginal sensitivity to pathogens during menopause In addition recent data show that vitamin E can counteract the production of biofilm produced by certain pathogens which has detrimental effects on the homeostasis of the vaginal environment
The period of observation is from January 1st 2020 to December 31st 2022 while the Data Collection period will be from June 30th 2023 to July 31st 2023
The period of observation is from January 1st 2020 to December 31st 2022 while the Data Collection period will be from June 30th 2023 to July 31st 2023
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None