title: Evaluation of the effects of a new intravaginal gel, containing purified bovine colostrum, on vaginal blood flow and vaginal atrophy in ovariectomized rat.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Zambon S.p.A. Bresso (Milan), Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Vailati
authors.affiliation: Zambon S.p.A. Bresso (Milan), Italy.
authors.forename: Elsa
authors.initials: E
authors.lastname: Melloni
authors.affiliation: Pharma Research Consulting s.r.l Milan, Italy.
authors.forename: Ermanno
authors.initials: E
authors.lastname: Riscassi
authors.affiliation: Pelvipharm Montigny-Le-Bretonneux, France ; EA 4501 Université Versailles Saint Quentin en Yvelines Montigny-Le-Bretonneux, France.
authors.forename: Delphine
authors.initials: D
authors.lastname: Behr Roussel
authors.affiliation: Zambon S.p.A. Bresso (Milan), Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Sardina
keywords: Bovine Colostrum; Ovariectomized Rat; Vaginal Atrophy; Vaginal Blood Flow