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

Phase 2

Completed

• Conditions: Vulvovaginal Atrophy; Menopause
• Interventions: Drug: Visnadine, prenylflavonoids and bovine colostrum

• Registration Number: NCT03281655
• Lead Sponsor: University of Messina

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.

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.

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2017-05
• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-13
• Study Completion: 2018-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vulvovaginal atrophy	Visnadine, prenylflavonoids and bovine colostrum	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.

Primary Outcome Measures

Name	Time	Method
Female sexual function index (FSFI) questionnaire	Post-treatment (15 days)	Desire, arousal, lubrication, orgasm, satisfaction and pain.
Vaginal health index score (VHIS) evaluation	Post-treatment (15 days)	Elasticity, fluid volume and consistency, pH, epithelial integrity and moisture.

Secondary Outcome Measures

Name	Time	Method
Side effects	Post-treatment (15 days)	Number of side effects during/after the treatment.