Contraception
Volume 75, Issue 2 , Pages 136-141 , February 2007

Fourteen-day safety and acceptability study of the universal placebo gel

  • Jill L. Schwartz

      Affiliations

    • CONRAD, Eastern Virginia Medical School (EVMS), Arlington, VA 22209, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 703 524 4744; fax: +1 703 524 4770.
    • ,
  • Susan A. Ballagh

      Affiliations

    • CONRAD, EVMS, Norfolk, VA 23507, USA
    • ,
  • Cynthia Kwok

      Affiliations

    • Family Health International, Research Triangle Park, NC 27713, USA
    • ,
  • Christine K. Mauck

      Affiliations

    • CONRAD, Eastern Virginia Medical School (EVMS), Arlington, VA 22209, USA
    • ,
  • Debra H. Weiner

      Affiliations

    • Family Health International, Research Triangle Park, NC 27713, USA
    • ,
  • William F. Rencher

      Affiliations

    • CONRAD, Eastern Virginia Medical School (EVMS), Arlington, VA 22209, USA
    • ,
  • Marianne M. Callahan

      Affiliations

    • CONRAD, Eastern Virginia Medical School (EVMS), Arlington, VA 22209, USA

Received 12 May 2006 ,Revised 9 August 2006 ,Accepted 6 September 2006.

References 

  1. Maguire RA, Bergman N, Phillips DM. Comparison of microbicides for efficacy in protecting mice against vaginal challenge with herpes simplex virus type 2, cytotoxicity, antibacterial properties, and sperm immobilization. Sex Transm Dis. 2001;28:259–265
  2. Mauck C, Weiner DH, Ballagh S, et al. Single and multiple exposure tolerance study of polystyrene sulfonate gel: a phase I safety and colposcopy study. Contraception. 2004;70:77–83
  3. Tien D, Schnaare RL, Kang F, et al. In vitro and in vivo characterization of a potential universal placebo designed for use in vaginal microbicide clinical trials. AIDS Res Hum Retroviruses. 2005;10:845–853
  4. Walker R. Toxicology of sorbic acids and sorbates. Food Addit Contam. 1990;7:671–676
  5. CONRAD and World Health Organization . Manual for the standardization of colposcopy for the evaluation of vaginally administered products, Update 2000. Geneva, Switzerland/Arlington, VA: CONRAD/WHO; 2000;
  6. Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of Gram stain interpretation. J Clin Microbiol. 1991;29:297–301
  7. Ness RB, Hillier SL, Richter HE, et al. Douching in relation to bacterial vaginosis, lactobacilli, and facultative bacteria in the vagina. Obstet Gynecol. 2002;100:765–772
  8. Gentry YV, Hillier SL, Eschenbach DA. Evaluation of a rapid enzyme immunoassay test for detection of group B Streptococcus. Obstet Gynecol. 1991;78:397–401
  9. Mauck C, Weiner DH, Ballagh S, et al. Single and multiple exposure tolerance study of cellulose sulfate gel: a Phase I safety and colposcopy study. Contraception. 2001;64:383–391

PII: S0010-7824(06)00355-6

doi: 10.1016/j.contraception.2006.09.003

Contraception
Volume 75, Issue 2 , Pages 136-141 , February 2007

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