Evaluation of the Effects of a New Intravaginal Gel, Containing Purified Bovine Colostrum, on Vaginal Blood Flow and Vaginal Atrophy in Ovariectomized Rat

Sexual Medicine

Silvia Vailati MSc²  Elsa Melloni MSc²  Ermanno Riscassi MSc¹  Delphine Behr Roussel PhD³ 

[1] Pharma Research Consulting s.r.l, Milan, Italy;Zambon S.p.A., Bresso (Milan), Italy;Pelvipharm, Montigny-Le-Bretonneux, France

关键词: Vaginal Atrophy;    Bovine Colostrum;    Ovariectomized Rat;    Vaginal Blood Flow;   

DOI  :  10.1002/sm2.8

来源: Wiley

【 摘 要 】

Abstract

Introduction

Vaginal dryness due to vaginal atrophy is a common complaint of postmenopausal women, interfering with sexual function and quality of life. Hormone replacement therapy is the only effective therapy but with known risks that leave unmet medical needs. A new product, ZP-025 vaginal gel, containing purified (dialyzed lyophilized) bovine colostrum, has been developed for the treatment of vaginal dryness secondary to vaginal atrophy.

Aim

The study aims to investigate the effects of intravaginal application of ZP-025 on vaginal atrophy using an animal model.

Methods

Ovariectomized female Sprague-Dawley rats were used. Three weeks after surgery, rats were divided into four groups and treated for 4 weeks (twice a day) with placebo or ZP-025 at low (0.5%) or high (2.3%) concentrations of colostrum; in the control group, rats did not receive any treatment. Changes in vaginal blood flow due to pelvic nerve stimulation were assessed by laser Doppler flowmetry and vaginal tissue was collected for histological assay.

Main Outcome Measures

The main outcome measures were vaginal blood flow before and after pelvic nerve stimulation and histology of vaginal epithelium.

Results

Treatment with ZP-025 to ovariectomized rats induced an increase of vaginal blood flow parameters (vascular capacitance, amplitude and area under the curve of the response) in response to pelvic nerve stimulation compared with control group, statistically significant at 2.3%. Vaginal epithelium showed a physiological estrous cycle aspect in treated animals, with at least five cell layers vs. one or two cell layers in control rats. As expected from a topical formulation, systemic effects on body weights and uterine wet weights were not observed with application of ZP-025.

Conclusions

In this study, the new product ZP-025, containing purified colostrum, was shown to have beneficial effects on vaginal atrophy in ovariectomized rats, improving vaginal hemodynamics and thickness of vaginal epithelium. Vailati S, Melloni E, Riscassi E, Behr Roussel D, and Sardina M. Evaluation of the effects of a new intravaginal gel, containing purified bovine colostrum, on vaginal blood flow and vaginal atrophy in ovariectomized rat. Sex Med 2013;1:35–43.

【 授权许可】

CC BY-NC   
© 2013 The Authors. Sexual Medicine published by Wiley Periodicals, Inc. on behalf of International Society for Sexual Medicine.

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