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

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.

Timeline

Start

2016-12

Primary completion

2017-05

Completion

2018-01

Publications

• Background Slater C, Robinson AJ. Sexual health in adolescents. Clin Dermatol. 2014 Mar-Apr;32(2):189-95. doi: 10.1016/j.clindermatol.2013.08.002.
• Background Schwenkhagen A. Hormonal changes in menopause and implications on sexual health. J Sex Med. 2007 Mar;4 Suppl 3:220-6. doi: 10.1111/j.1743-6109.2007.00448.x.
• Background McCabe MP, Sharlip ID, Lewis R, Atalla E, Balon R, Fisher AD, Laumann E, Lee SW, Segraves RT. Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus Statement from the Fourth International Consultation on Sexual Medicine 2015. J Sex Med. 2016 Feb;13(2):144-52. doi: 10.1016/j.jsxm.2015.12.034.
• Background Avis NE, Brockwell S, Randolph JF Jr, Shen S, Cain VS, Ory M, Greendale GA. Longitudinal changes in sexual functioning as women transition through menopause: results from the Study of Women's Health Across the Nation. Menopause. 2009 May-Jun;16(3):442-52. doi: 10.1097/gme.0b013e3181948dd0.
• Background Avis NE, Colvin A, Bromberger JT, Hess R, Matthews KA, Ory M, Schocken M. Change in health-related quality of life over the menopausal transition in a multiethnic cohort of middle-aged women: Study of Women's Health Across the Nation. Menopause. 2009 Sep-Oct;16(5):860-9. doi: 10.1097/gme.0b013e3181a3cdaf.
• Background Dennerstein L, Hayes RD. Confronting the challenges: epidemiological study of female sexual dysfunction and the menopause. J Sex Med. 2005 Sep;2 Suppl 3:118-32. doi: 10.1111/j.1743-6109.2005.00128.x.
• Background Hayes R, Dennerstein L. The impact of aging on sexual function and sexual dysfunction in women: a review of population-based studies. J Sex Med. 2005 May;2(3):317-30. doi: 10.1111/j.1743-6109.2005.20356.x.
• Background Levine KB, Williams RE, Hartmann KE. Vulvovaginal atrophy is strongly associated with female sexual dysfunction among sexually active postmenopausal women. Menopause. 2008 Jul-Aug;15(4 Pt 1):661-6. doi: 10.1097/gme.0b013e31815a5168.
• Background Nappi RE, Palacios S, Particco M, Panay N. The REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey in Europe: Country-specific comparisons of postmenopausal women's perceptions, experiences and needs. Maturitas. 2016 Sep;91:81-90. doi: 10.1016/j.maturitas.2016.06.010. Epub 2016 Jun 15.
• Background Castelo-Branco C, Biglia N, Nappi RE, Schwenkhagen A, Palacios S. Characteristics of post-menopausal women with genitourinary syndrome of menopause: Implications for vulvovaginal atrophy diagnosis and treatment selection. Maturitas. 2015 Aug;81(4):462-9. doi: 10.1016/j.maturitas.2015.05.007. Epub 2015 May 30.
• Background Lethaby A, Ayeleke RO, Roberts H. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev. 2016 Aug 31;2016(8):CD001500. doi: 10.1002/14651858.CD001500.pub3.
• Background Derzko C, Elliott S, Lam W. Management of sexual dysfunction in postmenopausal breast cancer patients taking adjuvant aromatase inhibitor therapy. Curr Oncol. 2007 Dec;14 Suppl 1(Suppl 1):S20-40. doi: 10.3747/co.2007.151.
• Background Bassino E, Antoniotti S, Gasparri F, Munaron L. Effects of flavonoid derivatives on human microvascular endothelial cells. Nat Prod Res. 2016 Dec;30(24):2831-2834. doi: 10.1080/14786419.2016.1154053. Epub 2016 Mar 2.
• Background Caruso S, Mauro D, Cariola M, Fava V, Rapisarda AMC, Cianci A. Randomized crossover study investigating daily versus on-demand vulvar Visnadine spray in women affected by female sexual arousal disorder. Gynecol Endocrinol. 2018 Feb;34(2):110-114. doi: 10.1080/09513590.2017.1354366. Epub 2017 Jul 27.
• Background Schaefer O, Humpel M, Fritzemeier KH, Bohlmann R, Schleuning WD. 8-Prenyl naringenin is a potent ERalpha selective phytoestrogen present in hops and beer. J Steroid Biochem Mol Biol. 2003 Feb;84(2-3):359-60. doi: 10.1016/s0960-0760(03)00050-5. No abstract available.
• Background Nappi RE, Cagnacci A, Becorpi AM, Nappi C, Paoletti AM, Busacca M, Martella S, Bellafronte M, Tredici Z, Di Carlo C, Corda V, Vignali M, Bagolan M, Sardina M. Monurelle Biogel(R) vaginal gel in the treatment of vaginal dryness in postmenopausal women. Climacteric. 2017 Oct;20(5):467-475. doi: 10.1080/13697137.2017.1335703. Epub 2017 Jun 28.

Drugs

Indications