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Original research article| Volume 70, ISSUE 5, P415-422, November 2004

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Contraception by Ushercell��� (cellulose sulfate) in formulation: duration of effect and dose effectiveness

  • Robert A. Anderson
    Correspondence
    Corresponding author. Tel.: +1 312 942 5451; fax: +1 312 942 2771.
    Affiliations
    Department of Obstetrics and Gynecology, Rush University Medical Center, Chicago, IL 60612, USA

    The Program for the Topical Prevention of Conception and Disease (TOPCAD), Rush University Medical Center, Chicago, IL 60612, USA
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  • Kenneth Feathergill
    Affiliations
    Department of Obstetrics and Gynecology, Rush University Medical Center, Chicago, IL 60612, USA

    The Program for the Topical Prevention of Conception and Disease (TOPCAD), Rush University Medical Center, Chicago, IL 60612, USA
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  • Xiao-Hui Diao
    Affiliations
    Department of Obstetrics and Gynecology, Rush University Medical Center, Chicago, IL 60612, USA

    The Program for the Topical Prevention of Conception and Disease (TOPCAD), Rush University Medical Center, Chicago, IL 60612, USA
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  • Calvin Chany II
    Affiliations
    Department of Obstetrics and Gynecology, Rush University Medical Center, Chicago, IL 60612, USA

    The Program for the Topical Prevention of Conception and Disease (TOPCAD), Rush University Medical Center, Chicago, IL 60612, USA
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  • William F. Rencher
    Affiliations
    CONRAD/Eastern Virginia Medical School, Arlington, VA 22209, USA
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  • Lourens J.D. Zaneveld
    Affiliations
    Department of Obstetrics and Gynecology, Rush University Medical Center, Chicago, IL 60612, USA

    The Program for the Topical Prevention of Conception and Disease (TOPCAD), Rush University Medical Center, Chicago, IL 60612, USA
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  • Donald P. Waller
    Affiliations
    The Program for the Topical Prevention of Conception and Disease (TOPCAD), Rush University Medical Center, Chicago, IL 60612, USA

    Department of Biopharmaceutical Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA
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      Abstract

      This study evaluated contraception by formulated Ushercell���, a uniquely high-molecular-weight form of cellulose sulfate, in the rabbit. Variables included (1) dose effectiveness, (2) duration of effectiveness, and (3) formulation excipients. Vaginally applied carboxymethyl-cellulose-based Ushercell��� gel is contraceptive. A 6% gel is active for at least 18 h; partial activity is observed for at least 24 h. With an application���insemination interval of 0.5 h, Ushercell��� as low as 0.1% is contraceptive. Contraception is incomplete with 2% Ushercell��� and an application���insemination interval of 24 h. Ushercell��� formulations containing a relatively high concentration of Carbopol are ineffective contraceptives, whether the gel is applied before insemination or is premixed with spermatozoa before insemination. Contraceptive activity is restored in Ushercell��� formulations with lower Carbopol content. This study shows that formulated Ushercell��� is an effective, long-lasting contraceptive and, hence, is bioavailable when vaginally applied. Activity is dependent on the type and relative concentration of formulation excipients. These data support a projected successful outcome of further clinical trials.

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