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Tocopherol Acetate Vaginal Administration in Pre-peri and Postmenopausal Women

NCT05918848 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-06-26

No results posted yet for this study

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.

Conditions

  • Pre- Peri, and Postmenopausal Women

Interventions

DEVICE

Filme Gyno-V® Vaginal Ovules

Administration of tocopherol (Filme Gyno-V® Vaginal Ovules) for 14 days

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Gemelli Molise Hospital

    lead OTHER

Principal Investigators

  • Francesco Cosentino, PhD · U.O.C. Ginecologia Oncologica Gemelli Molise

  • Roberto Di Marco, PhD · Microbiologia e Microbiologia Clinica Dipartimento Medicina e Scienze per la salute "V. Tiberio" Università degli Studi del Molise Campobasso (Italy) Laboratory

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2023-07-30
Completion
2023-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918848 on ClinicalTrials.gov