a phase i randomized placebo controlled trial of the safety of 3% spl7013 gel (vivagel？) in healthy young women administered twice daily for 14 days我随机安慰剂对照试验阶段的安全3% spl7013凝胶(vivagel )在健康年轻女性管理每天两次为14天.pdfVIP

A Phase I Randomized Placebo Controlled Trial of the Safety of 3% SPL7013 Gel (VivaGelH) in Healthy Young Women Administered Twice Daily for 14 Days 1 2 3 4 5 Craig R. Cohen *, Joelle Brown , Anna-Barbara Moscicki , Elizabeth A. Bukusi , Jeremy R. A. Paull , Clare F. Price5, Stephen Shiboski6 1 Department of Obstetrics, Gynecology and Reproductive Science, University of California San Francisco, San Francisco, California, United States of America, 2 Department of Epidemiology, University of California Los Angeles, Los Angeles, California, United States of America, 3 Department of Pediatrics, University of California San Francisco, San Francisco, California, United States of America, 4 Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya, 5 Starpharma Pty Ltd, Melbourne, Australia, 6 Department of Biostatistics, University of California San Francisco, San Francisco, California, United States of America Abstract Objective: To assess the safety of VivaGelH used vaginally twice daily for 14 days among healthy, sexually-abstinent women, aged 18–24 years in the USA and Kenya. Design: Randomized placebo controlled trial. Methods: Participants were randomized 2:1, VivaGel to placebo. Safety was assessed by comparing genitourinary (GU) adverse events (AEs), colposcopy findings, vaginal lactobacilli and laboratory abnormalities by arm. Results: Fifty-four women were enrolled; 35 in the VivaGel arm and 19 in the placebo arm. Twenty-six (74%) and 10 (53%) women reported taking all doses of VivaGel and placebo, respectively. No grade 3 or 4 AEs, or serious AEs occurred. Twenty- five (71%) participants in the VivaGel arm compared to 10 (53%) participants in the placebo arm had at least one grade 1 or 2 GU A