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

NCT03281655 | Completed Phase 2 DMC

• 1 other identifier: REFEEL-1
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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

Vulvovaginal Atrophy; Menopause

Keywords

Visnadine; Prenylflavonoids; Bovine colostrum; Sexual wellbeing

Outcome Measures

Primary Outcomes (2)

• Vaginal health index score (VHIS) evaluation

  Elasticity, fluid volume and consistency, pH, epithelial integrity and moisture.

  Post-treatment (15 days)

• Female sexual function index (FSFI) questionnaire

  Desire, arousal, lubrication, orgasm, satisfaction and pain.

  Post-treatment (15 days)

Secondary Outcomes (1)

• Side effects

  Post-treatment (15 days)

Study Arms (1)

Vulvovaginal atrophy

EXPERIMENTAL

Postmenopausal sexually active women affected by vulvovaginal atrophy undergoing treatment (15 days, 1 application per day) with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum.

Drug: Visnadine, prenylflavonoids and bovine colostrum

Interventions

Visnadine, prenylflavonoids and bovine colostrum DRUG

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

Vulvovaginal atrophy

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• postmenopausal sexually active women affected by vulvovaginal atrophy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Messina: lead
• University of Victoria: collaborator
• University of Athens: collaborator

Related Publications (16)

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  PMID: 24559553 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.

  PMID: 17394594 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.

  PMID: 26953829 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.

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• 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.

  PMID: 19436224 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.

  PMID: 16422789 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.

  PMID: 16422862 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.

  PMID: 18698279 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.

  PMID: 27451325 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.

  PMID: 26071816 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.

  PMID: 27577677 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.

  PMID: 18087605 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.

  PMID: 26936689 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.

  PMID: 28749253 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.

  PMID: 12711023 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.

  PMID: 28657769 BACKGROUND

MeSH Terms

Interventions

visnadin

Study Officials

• Antonio Simone Laganà, M.D.

  University of Messina

  PRINCIPAL INVESTIGATOR

• Salvatore Giovanni Vitale, M.D.

  University of Messina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Single cohort study

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 13, 2017
• Study Start: December 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 25, 2020

Record last verified: 2020-03