title: Daily application of alprostadil topical cream (Vitaros) does not impact vaginal pH, flora, or histology in female cynomolgus monkeys.
abstract: Topical alprostadil cream (Vitaros) is approved in Canada and Europe for the treatment of erectile dysfunction. To determine the effects on the female urogenital tract with repeated administration of the entire dose (300 μg alprostadil containing 2.5% dodecyl-2-n,n-dimethylaminopropionate hydrochloride), the vaginal pH, flora, and histology were assessed as a model for 100% transference from male to the female during unprotected sexual intercourse. Female cynomolgus monkeys were administered the entire dose of Vitaros for 14 days with a 7-day recovery. Relative to vehicle and placebo cream, the vaginal pH and microflora were determined at baseline and weekly, thereafter. Vaginal biopsies were evaluated at the end of dosing and recovery. All animals were clinically normal for the study duration, and the vaginal pH was consistent between dose groups and the dosing period. Vaginal microflora and histopathology findings of mild inflammation were generally similar across treatment groups. In conclusion, repeated vaginal exposure to Vitaros did not alter the pH, microflora, or histology after 14 daily doses, supporting the safety of Vitaros transference to the female partner.
authors.affiliation: Apricus Biosciences, San Diego, CA, USA smeierdavis@apricusbio.com.
authors.forename: Susan R
authors.initials: SR
authors.lastname: Meier-Davis
authors.affiliation: Apricus Biosciences, San Diego, CA, USA.
authors.forename: Salma
authors.initials: S
authors.lastname: Debar
authors.affiliation: Biotox Sciences, San Diego, CA, USA.
authors.forename: Jacob
authors.initials: J
authors.lastname: Siddoway
authors.affiliation: Biotox Sciences, San Diego, CA, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Rabe
mesh_terms: D000282:Administration, Intravaginal; D000527:Alprostadil / Q000008:administration & dosage / Q000633:toxicity*; D000818:Animals; D058491:Bacterial Load; D005260:Female; D006863:Hydrogen-Ion Concentration; D007778:Lactobacillus / Q000302:isolation & purification; D008252:Macaca fascicularis; D064307:Microbiota; D013211:Staphylococcus aureus / Q000302:isolation & purification; D064804:Urological Agents / Q000008:administration & dosage / Q000633:toxicity*; D014621:Vagina / Q000033:anatomy & histology / Q000737:chemistry / Q000187:drug effects* / Q000382:microbiology; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000633:toxicity*
chemical_list: D064804:Urological Agents; D014665:Vasodilator Agents; D000527:Alprostadil
keywords: alprostadil; cynomolgus; dodecyl-2-n; monkey; n-dimethylaminopropionate hydrochloride; prostaglandin E1; topical; vagina