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

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Messina
• Collaborators: University of Athens; University of Victoria

Criteria

Inclusion Criteria:

• postmenopausal sexually active women affected by vulvovaginal atrophy.

Exclusion Criteria:

• relevant comorbidities (chronic cardiovascular, immune, endocrine and metabolic diseases and cancers);

• smokers;

• who used any other kind of pharmacologic treatment (including the substances tested in this study) in the previous 3 months.