title: 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.
abstract: OBJECTIVE
  To assess the safety of VivaGel® used vaginally twice daily for 14 days among healthy, sexually-abstinent women, aged 18-24 years in the USA and Kenya.
  
  
  METHODS
  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 AE associated with product use (RR = 1.4, 95% CI 0.8-2.2). All seven grade 2 GU AEs associated with product use occurred among four women in the VivaGel arm. Vulvar and cervical erythema, cervical lesions, symptomatic BV, urinary frequency and metrorrhagia were more common in the VivaGel arm than the placebo arm. Twenty-nine (83%) participants in the VivaGel arm had a colposcopic finding compared to 10 (53%) participants in the placebo arm (RR = 1.6, 95%CI = 1.0-2.5). Two women in the VivaGel arm prematurely discontinued product use themselves due to a reported GU AE. Persistence of H₂O₂-producing and non-producing lactobacilli did not differ by study arm.
  
  
  CONCLUSIONS
  GU AEs and colposcopic findings consistent with mild epithelial irritation and inflammation occurred more commonly among women in the VivaGel arm.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT003311032.
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Science, University of California San Francisco, San Francisco, California, United States of America. ccohen@globalhealth.ucsf.edu
authors.forename: Craig R
authors.initials: CR
authors.lastname: Cohen
authors.forename: Joelle
authors.initials: J
authors.lastname: Brown
authors.forename: Anna-Barbara
authors.initials: AB
authors.lastname: Moscicki
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Bukusi
authors.forename: Jeremy R A
authors.initials: JR
authors.lastname: Paull
authors.forename: Clare F
authors.initials: CF
authors.lastname: Price
authors.forename: Stephen
authors.initials: S
authors.lastname: Shiboski
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects*; D003127:Colposcopy; D050091:Dendrimers; D064420:Drug-Related Side Effects and Adverse Reactions; D004890:Erythema / Q000139:chemically induced; D005260:Female; D052776:Female Urogenital Diseases / Q000139:chemically induced / Q000517:prevention & control; D005782:Gels / Q000627:therapeutic use; D006801:Humans; D007630:Kenya; D007778:Lactobacillus / Q000302:isolation & purification; D011107:Polylysine / Q000008:administration & dosage / Q000009:adverse effects*; D012746:Sexual Abstinence; D014481:United States; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D050091:Dendrimers; D005782:Gels; D011107:Polylysine; C480351:astodrimer