Objective: To evaluate the effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and bovine colostrum (1%) on Vaginal Health Index Score (VHIS) and Female Sexual Function Index (FSFI) in post-menopausal sexually active women affected by vaginal dryness. Patients and methods: We performed a prospective pilot study, enrolling 15 post-menopausal sexually active women affected by vaginal dryness. The mean age of participants was 56.8 ± 4.6 years with parity mean 1.6 ± 1. All women gave consent and underwent VHIS evaluation and FSFI test. Following baseline evaluation, women underwent 15 days of vaginal treatment with one application per day of the new vaginal cream. Following treatment, women were evaluated again using the same methods of the pre-treatment phase. Results: Following treatment there was significant improvement in elasticity (p = 0.03), fluid secretion type and consistency (p = 0.01), pH (p = 0.03), epithelization of vaginal mucosa (p = 0.04), moisture (p = 0.04) and total VHIS (p = 0.0001). Similarly, after the treatment there was also a significant improvement of lubrication (p = 0.01), orgasm (p = 0.01), satisfaction (p = 0.02), pain (p = 0.03) and total FSFI score (p = 0.004). No significant differences regarding desire (p = 0.57) and arousal (p = 0.61) were found. None of the women reported any local or systemic side effect during the treatment. Conclusion: We demonstrated a significant improvement of both VHIS and FSFI score in post-menopausal sexually active women after a treatment with vaginal cream containing visnadine, prenylflavonoids and bovine colostrum. Given that our results are based on a pilot study, we postulate that the treatment with this new vaginal cream may significantly reduce vaginal dryness in post-menopausal women and improve their sexual wellbeing.

1. Dr. Antonio Simone Laganà
Unit of Gynecology and Obstetrics, Department of
Human Pathology in Adulthood and Childhood “G.
Barresi”, University of Messina, Messina, Italy.
Effects of a new vaginal cream containing visnadine,
prenylflavonoids and bovine colostrum on Vaginal Health
Index Score and Female Sexual Function Index in post-
menopausal sexually active women affected by vaginal
dryness: a pilot study
Junior Mentorship Programme
Prof. Lily Stojanovska
Centre for Chronic Disease, College of Health &
Biomedicine, Victoria University,
Melbourne, VIC, Australia.

2. Disclosure
I have no actual or potential conflict of interest,
including commercial or financial relationship,
regarding this presentation.

3. Background and Rationale
Accumulating evidence suggests that sexual health plays a
pivotal role through women’s lives, from puberty to the post-
menopausal period.
Despite the necessity of
additional epidemiological data,
it is widely accepted that female
sexual dysfunction (FSD)
increases as women age and
affects about 40-45% of adult
women.
(Burri et al, J Sex Med, 2015)

4. Background and Rationale
Study of Women’s Health Across the Nation (SWAN)
3,302 U.S. women (aged 42 to 52 years):
decrease in sexual desire and an increase in painful intercourse
during peri-menopause.
(Avis et al, Menopause, 2009)

5. Background and Rationale
Women’s Healthy Ageing Project
230 Australian post-menopausal women:
women maintaining sexual activity had stability in sexual
functioning, whereas inactive women reported an overall decline.
(Lonnèe-Hoffmann et al, J Sex Med, 2014)

6. Background and Rationale
Some conditions associated with
hormonal changes at menopause,
such as vulvovaginal atrophy, have a
significant impact on sexual
function and QoL.
In particular, these effects are documented by a severe
decrease of both Female Sexual Function Index (FSFI) and
Vaginal Health Index (VHI) score in post-menopausal
women affected by vulvovaginal atrophy.
(Nappi et al, Maturitas, 2016)

7. Background and Rationale
Women with positive scores for FSD are almost 4 times
more likely to have vulvovaginal atrophy respect to women
not reporting sexual symptoms.
(Levine et al, Menopause, 2008)

8. Background and Rationale
The CLOSER study: vulvovaginal atrophy has an adverse
emotional and physical impact on post-menopausal women
and their partners.
(Nappi et al, J Sex Med, 2013)

9. Background and Rationale
Visnadine, which is found in Ammi
visnaga, showed powerful
biological activity as vasodilator
and has also anti-inaflammatory
properties.
(Lee et al, Arch Pharm Res, 2010)
Flavonoids have been showed to play a beneficial role for
vaginal atrophy in post-menopausal women.
(Lethaby et al, Cochrane Database Syst Rev, 2016)
Purified bovine colostrum was able to increase vaginal
blood flow and ameliorate vaginal atrophy in
ovariectomized rats.
(Vailati et al, Sex Med, 2013)

10. Background and Rationale
The aim of this study was to evaluate the effects of a
new vaginal cream containing visnadine,
prenylflavonoids and bovine colostrum on Female
Sexual Function Index and Vaginal Health Index Score
in post-menopausal sexually active women affected
by vaginal dryness.

11. Patients and Methods
Single-center, prospective, pilot cohort study at the
Department of Obstetrics and Gynecology of the University
of Messina, between November and December 2016.

12. Patients and Methods
We enrolled 15 post-menopausal sexually active women
affected by vaginal dryness.
Exclusion criteria:
• significant comorbidities (chronic cardiovascular,
immune, endocrine, and metabolic disorders,
cancers)
• any other kind of pharmacological treatment
during the previous 3 months.
The study:
• was not advertised and no remuneration was offered to the
patients;
• conforms the STROBE statement (EQUATOR network);
• was approved by an independent Institutional Review Board.
All the patients signed informed consent allowing data collection
for research purpose.

13. Patients and Methods
All enrolled patients underwent baseline
evaluation by FSFI and VHI score.
Following baseline evaluation, patients
underwent 15 days of treatment with one
application per day of the new vaginal
cream, containing visnadine (0.30%),
prenylflavonoids (0.10%) and bovine
colostrum (1%).
We did not record any side effect during the
treatment.
After treatment, women were evaluated
again using the same methods of the pre-
treatment phase.

14. Patients and Methods
Female Sexual Function Index
(Rosen et al, J Sex Marital Ther, 2000)

15. Patients and Methods
Vaginal Health Index
(Bachman et al, Clin Pr Sex, 1992)

16. Results
Female Sexual
Function Index
parameters
Pre-treatment
(Mean ± Standard
Deviation)
Post-treatment
(Mean ± Standard
Deviation)
p
Desire 3,4 ± 1 3,6 ± 0,9 0,57
Arousal 3,9 ± 1 4,1 ± 1,1 0,61
Lubrication 3,4 ± 0,7 4,3 ± 1,1 0,01
Orgasm 4 ± 1 4,8 ± 0,6 0,01
Satisfaction 4,3 ± 0,9 4,9 ± 0,3 0,02
Pain 3,7 ± 0,9 4,6 ± 1,3 0,03
Female Sexual
Function Index
score
22,4 ± 4,2 26,1 ± 2,4 0,004
Table 1. Comparison of Female Sexual Function Index between pre-
treatment and post-treatment phases.

17. Results
Table 2. Comparison of Vaginal Health Index score between pre-
treatment and post-treatment phases.
Vaginal Health
Index parameters
Pre-treatment
(Mean ± Standard
Deviation)
Post-treatment
(Mean ± Standard
Deviation)
p
Elasticity 1,9 ± 0,7 2,7 ± 1,1 0,03
Fluid secretion type
and consistency
2 ± 0,6 2,8 ± 1,1 0,01
pH 2,5 ± 0,9 3,3 ± 1 0,03
Epithelial integrity 2,9 ± 1,1 3,8 ± 1,2 0,04
Moisture 2,4 ± 0,6 3,1 ± 1,1 0,04
Vaginal Health
Index score
11,7 ± 1,9 15,7 ± 2,5 0,0001

18. Conclusion
The treatment with this new vaginal cream may
significantly reduce vaginal dryness and improve
sexual wellbeing in post-menopausal women.
We found significant improvement
of both FSFI and VHI scores after
treatment with vaginal cream
containing visnadine,
prenylflavonoids and bovine
colostrum.

19. Thanks for your
attention!