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

March 23, 2020 updated by: Antonio Simone Laganà, University of Messina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: Post-treatment (15 days)
Number of side effects during/after the treatment.
Post-treatment (15 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Messina

Collaborators

University of Victoria
University of Athens

Investigators

  • Principal Investigator: Antonio Simone Laganà, M.D., University of Messina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REFEEL-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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