Contraception
Volume 77, Issue 2 , Pages 130-137 , February 2008

A Phase I study of the functional performance, safety and acceptability of the BufferGel® Duet™

  • Susan A. Ballagh

      Affiliations

    • CONRAD Clinical Research Center, Eastern Virginia Medical School Norfolk, VA 23507, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 757 446 7444; fax: +1 757 446 8998.
    • ,
  • Vivian Brache

      Affiliations

    • Profamilia, Zone 4, Apartado Postal 1053, Santo Domingo, Dominican Republic
    • ,
  • Christine Mauck

      Affiliations

    • CONRAD, Arlington, VA 22209, USA
    • ,
  • Marianne M. Callahan

      Affiliations

    • CONRAD, Arlington, VA 22209, USA
    • ,
  • Leila Cochon

      Affiliations

    • Profamilia, Zone 4, Apartado Postal 1053, Santo Domingo, Dominican Republic
    • ,
  • Angie Wheeless

      Affiliations

    • Family Health International, Durham, NC 27713, USA
    • ,
  • Thomas R. Moench

      Affiliations

    • ReProtect Inc., Baltimore, MD 21286, USA

Received 29 August 2007 ,Revised 20 October 2007 ,Accepted 29 October 2007.

References 

  1. Olmsted SS, Dubin NH, Cone RA, Moench TR. The rate at which human sperm are immobilized and killed by mild acidity. Fertil Steril. 2000;73:687–693
  2. Olmsted SS, Khanna KV, Ng EM, et al. Low pH immobilizes and kills human leukocytes and prevents transmission of cell-associated HIV in a mouse model. BMC Infect Dis. 2005;5:79
  3. 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
  4. Zeitlin L, Hoen TE, Achilles SL, et al. Tests of Buffergel for contraception and prevention of sexually transmitted diseases in animal models. Sex Transm Dis. 2001;28:417–423
  5. Mayer KH, Peipert J, Fleming T, et al. Safety and tolerability of BufferGel, a novel vaginal microbicide, in women in the United States. Clin Infect Dis. 2001;32:476–482
  6. van De Wijgert J, Fullem A, Kelly C, et al. Phase 1 trial of the topical microbicide BufferGel: safety results from four international sites. J Acquir Immune Defic Syndr. 2001;26:21–27
  7. Barnhart KT, Rosenberg MJ, MacKay HT, et al. Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial. Obstet Gynecol. 2007;110:577–586
  8. Diseases characterized by urethritis and cervicitis 2007. (Accessed Sept 24, 2007, at http://www.cdc.gov/STD/treatment/2006/urethritis-and-cervicitis.htm#uc4.)
  9. Moench TR, Chipato T, Padian NS. Preventing disease by protecting the cervix: the unexplored promise of internal vaginal barrier devices. AIDS. 2001;15:1595–1602
  10. Pudney J, Quayle AJ, Anderson DJ. Immunological microenvironments in the human vagina and cervix: mediators of cellular immunity are concentrated in the cervical transformation zone. Biol Reprod. 2005;73:1253–1263
  11. Barnhart KT, Pretorius ES, Timbers K, Shera D, Shabbout M, Malamud D. In vivo distribution of a vaginal gel: MRI evaluation of the effects of gel volume, time and simulated intercourse. Contraception. 2004;70:498–505
  12. Padian NS, van der Straten A, Ramjee G, et al. Diaphragm and lubricant gel for prevention of HIV acquisition in Southern African women: a randomised controlled trial. Lancet. 2007;370:251–261
  13. Barnhart KT, Pretorius ES, Shaunik A, Timbers K, Nasution M, Mauck C. Vaginal distribution of two volumes of the novel microbicide gel cellulose sulfate (2.5 and 3.5 mL). Contraception. 2005;72:65–70
  14. 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
  15. Doh AS, Ngoh N, Roddy R, Lai JJ, Linton K, Mauck C. Safety and acceptability of 6% cellulose sulfate vaginal gel applied four times per day for 14 days. Contraception. 2007;76:245–249
  16. Mauck CK, Weiner DH, Creinin MD, et al. FemCap with removal strap: ease of removal, safety and acceptability. Contraception. 2006;73:59–64
  17. Schwartz JL, Ballagh SA, Kwok C, et al. Fourteen-day safety and acceptability study of the universal placebo gel. Contraception. 2007;75:136–141
  18. Williams DL, Newman DR, Ballagh SA, et al. Phase 1 safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Sex Transm Dis. 2007;34(12):977–984
  19. Fraser IS, Lahteenmaki P, Elomaa K, et al. Variations in vaginal epithelial surface appearance determined by colposcopic inspection in healthy, sexually active women. Hum Reprod. 1999;14:1974–1978

☆ Support for this project was provided by CONRAD, Eastern Virginia Medical School, under a Cooperative Agreement with the United States Agency for International Development (USAID). The study product was supplied by ReProtect, Baltimore, MD.

☆☆ The views expressed by the authors do not necessarily reflect the views of USAID.

PII: S0010-7824(07)00455-6

doi: 10.1016/j.contraception.2007.10.003

Contraception
Volume 77, Issue 2 , Pages 130-137 , February 2008

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