Tocopherol Acetate Vaginal Administration in Pre-peri and Postmenopausal Women

Gemelli Molise Hospital

Status: Not yet enrolling

Conditions: Pre- Peri, and Postmenopausal Women

Treatments: Device: Filme Gyno-V® Vaginal Ovules

Study type: Observational

Funder types: Other

Identifiers

NCT05918848

GEMMOL GYNE 01/2023

Details and patient eligibility

About

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.

Full description

The vaginal microbiota has a significant bearing on a woman's 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

Enrollment: 50 estimated patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged ≥ 50 to ≤ 70 years included.
• Premenopause, perimenopause,postmenopause women (according to STRAW criteria)
• Patients able to comply with the requirements for the study and freely willing to provide written informed consent to the retrospectively collection of their data.

Exclusion criteria

• Malignancy (also leukemic infiltrates) within 5 years prior to day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
• Genital bleeding.
• Oestrogen topical (vaginal) treatment during the study period (it must have been terminated at least 6 months before the beginning of the study).
• Systemic oestrogen therapy during the study period (it must have been terminated at least 6 months before the beginning of the study).
• Patients with any illness, or any other medical condition, that, in the opinion of the Investigator, would compromise the participation or be likely to lead to hospitalisation during the study.
• Clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhoea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (e.g., tuberculosis).
• Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
• Known allergy to tested medical device (tocopherol day 0.
• Participation in an interventional clinical study or administration of any investigational agents in the 30 days prior to day 0.
• Presence of any clinically significant medical condition judged by the Investigator to preclude the patient's inclusion in the study.