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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03281655
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : March 25, 2020
University of Victoria
University of Athens
Information provided by (Responsible Party):
Antonio Simone Laganà, 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.

Condition or disease Intervention/treatment Phase
Vulvovaginal Atrophy Menopause Drug: Visnadine, prenylflavonoids and bovine colostrum Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a New Vaginal Cream Containing Visnadine, Prenylflavonoids and Bovine Colostrum in Postmenopausal Sexually Active Women Affected by Vulvovaginal Atrophy: a Prospective Cohort Analysis
Actual Study Start Date : December 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vulvovaginal atrophy
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
15 days, 1 application per day, with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum.

Primary Outcome Measures :
  1. Vaginal health index score (VHIS) evaluation [ Time Frame: Post-treatment (15 days) ]
    Elasticity, fluid volume and consistency, pH, epithelial integrity and moisture.

  2. Female sexual function index (FSFI) questionnaire [ Time Frame: Post-treatment (15 days) ]
    Desire, arousal, lubrication, orgasm, satisfaction and pain.

Secondary Outcome Measures :
  1. Side effects [ Time Frame: Post-treatment (15 days) ]
    Number of side effects during/after the treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03281655

Sponsors and Collaborators
University of Messina
University of Victoria
University of Athens
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Principal Investigator: Antonio Simone Laganà, M.D. University of Messina
Principal Investigator: Salvatore Giovanni Vitale, M.D. University of Messina

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Responsible Party: Antonio Simone Laganà, Medical Doctor, University of Messina Identifier: NCT03281655    
Other Study ID Numbers: REFEEL-1
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Simone Laganà, University of Messina:
Bovine colostrum
Sexual wellbeing
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical