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Visnadine, Prenylflavonoids and Bovine Colostrum to Treat Vulvovaginal Atrophy in Postmenopausal Women

NCT03281655 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-03-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Visnadine, prenylflavonoids and bovine colostrum

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

Sponsors & Collaborators

  • University of Victoria

    collaborator OTHER

  • University of Athens

    collaborator OTHER

  • University of Messina

    lead OTHER

Principal Investigators

  • Antonio Simone Laganà, M.D. · University of Messina

  • Salvatore Giovanni Vitale, M.D. · University of Messina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-05-31
Completion
2018-01-31

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Entities

Diseases

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 NCT03281655 on ClinicalTrials.gov