Dextrin Sulfate as a Vaginal Microbicide: Randomized, Double-Blind, Placebo-Controlled Trial Including Healthy Female Volunteers and Their Male Partners

• Published in: Journal of acquired immune deficiency syndromes (1999) Vol. 31; no. 4; pp. 391 - 398
• Main Authors: Low-Beer, Naomi, Gabe, Rhian, McCormack, Sheena, Kitchen, Valerie S, Lacey, Charles J, Nunn, Andrew J
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins, Inc 01-12-2002; Lippincott Williams & Wilkins; Lippincott Williams & Wilkins Ovid Technologies
• Subjects: Adult; Anti-Infective Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; Clinical trials; Colposcopy; Dextrins - adverse effects; Dextrins - therapeutic use; Double-Blind Method; Ethnic Groups; Female; General aspects; HIV Infections - epidemiology; HIV Infections - prevention & control; Humans; Male; Medical sciences; Pharmacology. Drug treatments; Placebos; Preventive medicine; Reference Values; Risk Assessment; Sexual Behavior; Sexually transmitted diseases; Sexually Transmitted Diseases - epidemiology; STD; Vagina - pathology; Vulva - pathology; Women; Human; Dextrin derivatives; Treatment; Treatment efficiency; Double blind study; Vagina; Safety; Sulfates; Antimicrobial agent
• ISSN: 1525-4135; 1944-7884
• DOI: 10.1097/00126334-200212010-00004

This randomized, placebo-controlled trial assessed the safety and acceptability of vaginally administered 0.125% dextrin sulfate (DS) gel in sexually active women and their male partners. A single 2-mL dose of study gel was self-administered every night over two 14-day periods separated by a 7-day interval, during which menses was expected to occur. Up to two supplementary doses per 24 hours were provided for use before sexual intercourse. Semistructured interview, colposcopy, and laboratory safety studies were used to assess adverse events. Male partners who agreed to participate in a substudy were exposed to gel through sexual intercourse during the second 14-day exposure period. Seventy-three women (36 DS recipients and 37 placebo recipients) used at least one application of gel, of whom 66 (33 DS recipients and 33 placebo recipients) completed follow-up. Eleven women (5 DS recipients and 6 placebo recipients) reported intermenstrual bleeding during gel use, which in most cases was light and resolved within 24 hours. Ten male partners (4 with DS exposure and 6 with placebo exposure) were enrolled in the study and all completed follow-up. There was no evidence of systemic toxicity or genital epithelial disruption attributable to DS gel.