title: A placebo-controlled, double-blind prospective study in healthy female volunteers of dextrin sulphate gel: a novel potential intravaginal virucide.
abstract: A double-blind, placebo-controlled study was designed to evaluate the safety and tolerability of intravaginal dextrin sulphate (D2S) gel to assess its preliminary suitability as a potential vaginal virucide. Tolerability was assessed by questionnaire and patient interview. Colposcopy with vaginal biopsy was performed to assess the macroscopic and microscopic evidence of inflammation. The potential impact of the gel on normal vaginal flora was examined by quantitative lactobacilli culture with assessment of the ratio of peroxide to nonperoxide-producing organisms. Colposcopy revealed mild erythema in five of 24 subjects receiving active gel and in none of the 12 placebo recipients, but histology in all subjects revealed no evidence of inflammation. No impact on vaginal lactobacilli was found. We conclude that D2S gel is safe and well tolerated intravaginally at the dosing schedule used in this study.
authors.affiliation: Department of Genitourinary Medicine and Communicable Diseases (Clinical Trials Centre, Jefferiss Research Trust Laboratories and MRC Sexually Transmitted Diseases Research Group), Chelsea and Westminister Hospital, London, England.
authors.forename: M K
authors.initials: MK
authors.lastname: Stafford
authors.forename: D
authors.initials: D
authors.lastname: Cain
authors.forename: I
authors.initials: I
authors.lastname: Rosenstein
authors.forename: E A
authors.initials: EA
authors.lastname: Fontaine
authors.forename: M
authors.initials: M
authors.lastname: McClure
authors.forename: A M
authors.initials: AM
authors.lastname: Flanagan
authors.forename: J R
authors.initials: JR
authors.lastname: Smith
authors.forename: D
authors.initials: D
authors.lastname: Taylor-Robinson
authors.forename: J
authors.initials: J
authors.lastname: Weber
authors.forename: V S
authors.initials: VS
authors.lastname: Kitchen
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000494:pharmacology*; D001706:Biopsy; D003127:Colposcopy; D003912:Dextrins / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D015658:HIV Infections / Q000517:prevention & control; D006801:Humans; D007407:Interviews as Topic; D008875:Middle Aged; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D014621:Vagina / Q000382:microbiology; D014622:Vaginal Creams, Foams, and Jellies / Q000009:adverse effects / Q000494:pharmacology
chemical_list: D000998:Antiviral Agents; D003912:Dextrins; D014622:Vaginal Creams, Foams, and Jellies; C091377:dextrin 2-sulfate