Visnadine, Prenylflavonoids and Bovine Colostrum to Treat Vulvovaginal Atrophy in Postmenopausal Women
Condition: Vulvovaginal Atrophy; Menopause
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Sexual health plays a key role during women's lives from puberty to post-menopausal period
      and, for this reason, it has increasingly received public health, pharmaceutical, and medical
      attention. According to the study of women's health across the nation (SWAN), more than 75%
      of the middle-aged women reported that sex was moderately to extremely important; in
      addition, the menopausal transition was characterized by increasing pain during sexual
      intercourse and consequent decrease of sexual desire. Individual general health status,
      diabetes mellitus, cardiovascular diseases, other genitourinary diseases,
      psychiatric/psychological disorders, other chronic diseases and socio-demographic conditions
      may all influence post-menopausal sexual health. Although aging could be considered an
      independent risk factor for sexual dysfunction accumulating evidence suggests that
      vulvovaginal atrophy (VVA) is strongly associated with female sexual dysfunction (FSD) among
      sexually active postmenopausal women: in particular, VVA was found to be significantly
      associated with a global indication of FSD and difficulties with sexual desire, arousal, and
      orgasm. VVA often results from postmenopausal estrogen loss, which acts as a double-edged
      sword: on the one hand, it plays a detrimental action on woman's desire and arousal; on the
      other hand, it decreases the lubrication of the vagina before sexual activity and,
      consequently, causes pain during intercourse, precludes satisfaction and further decreases
      arousal.

      Although several pharmacological approaches have been evaluated for the relief of VVA. Local
      estrogens are considered a safe option for VVA, although many clinicians are hesitant to
      prescribe them and many women reluctant to use them. In addition, non-hormonal treatments
      such as moisturizers and precoital vaginal lubricants could be considered a safer
      alternative, even in cancer patients. In this regard, visnadine, an active ingredient of the
      fruit of Ammi visnaga, showed powerful vasodilatory activity, due to the inhibitory effects
      on vascular smooth muscles mediated by Ca2+ entry through voltage-gated L-type Ca2+ channels.
      In addition, visnadine improves both female sexual function index (FSFI) and color Doppler
      sonography of clitoral blood flow. Furthermore, prenylflavonoids and phytoestrogens play a
      potent role as estrogen receptor (ER)-alpha selective agonist, thus they may counteract the
      effects of postmenopausal estrogen loss. Finally, a vaginal cream containing bovine colostrum
      has been shown to be effective in relieving vaginal dryness and other VVA symptoms in
      postmenopausal women, after 8 weeks of treatment. Based on this information, the
      investigators aim to evaluate the effects of a new vaginal cream containing visnadine,
      prenylflavonoids and bovine colostrum on vaginal health index score (VHIS) and FSFI in a
      cohort of postmenopausal sexually active women affected by VVA.
    

Intervention name(s): Visnadine, prenylflavonoids and bovine colostrum
Intervention type(s): Drug
Intervention description(s): 15 days, 1 application per day, with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum.
Intervention model: Single Group Assignment
Intervention model description: Single cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Visnadine; Prenylflavonoids; Bovine colostrum; Sexual wellbeing