CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Visnadine, prenylflavonoids and bovine colostrumdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03281655
NCT03281655Phase 2Completed

Effects of a New Vaginal Cream Containing Visnadine, Prenylflavonoids and Bovine Colostrum in Postmenopausal Sexually Active Women Affected by Vulvovaginal Atrophy: a Prospective Cohort Analysis

University of Messina·interventional·Posted Sep 13, 2017·Updated Mar 25, 2020

In Brief

A Phase 2 clinical trial evaluating Visnadine, prenylflavonoids and bovine colostrum for Vulvovaginal Atrophy and Menopause. Completed, enrolled 54 participants.

Detailed Summary

The effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and bovine colostrum (1%) will be evaluated in post-menopausal sexually active women affected by vulvovaginal atrophy (VVA). In a prospective cohort study, post-menopausal women affected by VVA will be enrolled. All women will undergo vaginal health index score (VHIS) evaluation and will complete the female sexual function index (FSFI) questionnaire at baseline evaluation (T0) and following 15 days of vaginal cream treatment with one application per day (T1). All the side effects will be recorded and an independent data safety and monitoring committee will evaluate the results of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 13, 2017
Enrollment StartDec 1, 2016
Primary CompletionMay 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.8 years ago

Interventions

Visnadine, prenylflavonoids and bovine colostrumdrug

15 days, 1 application per day, with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum.