Trial reportJournal of endocrinological investigation2018
Efficacy and tolerability of a spray formulation containing Visnadine in women self-reporting sexual symptoms: a randomized double-blind placebo-controlled pilot study.
Trial report in Journal of endocrinological investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed, 7 citations in OpenAlex.
- Therapeutic Choices for Genitourinary Syndrome of Menopause (GSM) in Breast Cancer Survivors: A Systematic Review and Update.Pharmaceuticals (Basel, Switzerland) · 2023Review
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of this pilot, double-blind, randomized, placebo-controlled study, was to evaluate both the efficacy and the tolerability of a formulation for vulvar application containing Visnadine, a natural extractive substance with vasoactive properties, (ReFeel
methodsSixty women (age range 18-60 years) volunteered to test the product against placebo (PL): Two puffs in the vulvar area, 10 min before sexual stimulation, for 30 days and for a minimum of six times. The main outcome measure was the improvement of the Female Sexual Function Index (FSFI) score (cut-off ≤ 26.55 for female sexual dysfunction [FSD]). Secondary outcomes were sexual satisfaction and tolerability with the product.
resultsPL group (n = 28) and Visnadine group (n = 30) were comparable for age, sexual function and rate of FSD at baseline (T0). After 1 month (T1), women in Visnadine group scored from 25.0 ± 3.8 to 27.9 ± 2.4 (p < 0.001), whereas no changes were evident in PL group (from 25.4 ± 5.0 to 25.6 ± 4.7). Statistically significant differences at T1 were reported in women with a positive (p < 0.001) or a negative FSD diagnosis (p < 0.01) using active treatment. Women with FSD reported significantly more improvement in satisfaction with their sexual function when treated with Visnadine spray compared to PL (p < 0.001), as well as more excitation (p < 0.001), pleasure (p < 0.001) and less time to reach orgasm (p < 0.003). No significant side effects were evident in both groups.
conclusionsOn demand, 1-month use of Visnadine spray displayed positive effects on sexual function in women with and without FSD and it was well tolerated. Topical Visnadine may not only be part of multimodal strategies to manage clinically relevant sexual symptoms but also simply to help women to enhance their subjective impaired perception of sexual response.
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