Safety, tolerability, and pharmacokinetics of SPL7013 gel (VivaGel): a dose ranging, phase I study.

@article{OLoughlin2010SafetyTA,
  title={Safety, tolerability, and pharmacokinetics of SPL7013 gel (VivaGel): a dose ranging, phase I study.},
  author={John O'Loughlin and Iona Y. Millwood and Helen M McDonald and Clare F. Price and John M Kaldor and Jeremy R. A. Paull},
  journal={Sexually transmitted diseases},
  year={2010},
  volume={37 2},
  pages={100-4}
}
OBJECTIVES To evaluate safety, tolerability and systemic pharmacokinetics of escalating doses of SPL7013 Gel in healthy women. DESIGN : Randomized, double-blind, placebo-controlled dose-escalation trial. METHODS Thirty-seven healthy women were randomized to receive 3.5 g of 0.5% (N = 8), 1% (N = 8), or 3% (N = 9) SPL7013 Gel or placebo gel (N = 12), applied vaginally once daily for 7 consecutive days. Genital toxicity was determined by interview, physical examination, assessment of vaginal… CONTINUE READING

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