Retrospective Investigator-Initiated Trial on Tocopherol Acetate Vaginal Administration in Pre-and Postmenopausal Women

Diseases. 2024 Oct 2;12(10):237. doi: 10.3390/diseases12100237.

Abstract

Background: Menopause, a natural phase in a woman's life, often adversely affects physical, mental, sexual, and emotional well-being due to low estrogen levels. This study examines the impact of vaginal ovules with tocopherol acetate (Filme Gyno-V® ovules, manufactured by Panin Srl and distributed by Hulka Srl, Italy), 500 mg per ovule, on vaginal health in pre- and menopausal women.

Methods: Fifty women aged 50-70 were divided into menopausal (28) and premenopausal (22) cohorts and treated with the ovules for two weeks, with assessments before and after treatment.

Results: The findings showed that distressing symptoms of vaginal atrophy, such as dryness, itching, and pain during intercourse, were resolved post-treatment. A molecular analysis revealed a reduction in Escherichia coli in both cohorts and an increase in three species of Lactobacillus in premenopausal patients.

Conclusions: This study concludes that Filme Gyno-V ovules may benefit vaginal health by alleviating atrophy symptoms and promoting healthy vaginal microbiota.

Keywords: Lactobacillus; eubiosis; genitourinary syndrome (GSM); menopause; microbial diversity indices; tocopherol acetate; vaginal atrophy; vaginal health; vaginal microbiota; vitamin E administration.

Grants and funding

This research was partially supported by COIIM-CONSORZIO INTERUNIVERSITARIO PER L’INGEGNERIA E LA MEDICINA, Campobasso (CB), Italy; this support was provided to Prof. Roberto Di Marco. The funder has no role in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript.