Contraception
Volume 81, Issue 3 , Pages 232-239 , March 2010

Results of a safety and feasibility study of the diaphragm used with ACIDFORM Gel or K-Y® Jelly

  • Claire E. von Mollendorf

      Affiliations

    • Reproductive Health and HIV Research Unit (RHRU), University of the Witwatersrand, Hugh Solomon Building, Hillbrow Health Precinct, Johannesburg, 2001, South Africa
    • Corresponding Author InformationCorresponding author. Tel.: +27 11 358 5500; fax: +27 11 358 5400.
  • ,
  • Lut. Van Damme

      Affiliations

    • Family Health International (FHI), Research Triangle Park, NC 27713, USA
  • ,
  • Jocelyn A. Moyes

      Affiliations

    • Reproductive Health and HIV Research Unit (RHRU), University of the Witwatersrand, Hugh Solomon Building, Hillbrow Health Precinct, Johannesburg, 2001, South Africa
  • ,
  • Vera Helen Rees

      Affiliations

    • Reproductive Health and HIV Research Unit (RHRU), University of the Witwatersrand, Hugh Solomon Building, Hillbrow Health Precinct, Johannesburg, 2001, South Africa
  • ,
  • Marianne M. Callahan

      Affiliations

    • CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA
  • ,
  • Christine K. Mauck

      Affiliations

    • CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA
  • ,
  • Adrian J. Puren

      Affiliations

    • Specialized Molecular Diagnostics Unit, National Institute for Communicable Diseases (NICD), Modderfontein Road, Sandringham, Johannesburg 2131, South Africa
  • ,
  • Kathryn Tweedy

      Affiliations

    • Family Health International (FHI), Research Triangle Park, NC 27713, USA
  • ,
  • Doug Taylor

      Affiliations

    • Family Health International (FHI), Research Triangle Park, NC 27713, USA

Received 14 April 2009 ,Revised 15 October 2009 ,Accepted 27 October 2009.

References 

  1. Garg S, Anderson RA, Chany CJ, et al. Properties of a new acid-buffering bioadhesive vaginal formulation (ACIDFORM). Contraception. 2001;64:67–75
  2. Pilipenko V, Bourne N, Zaneveld LJD, Garg S, Waller DP, Stanberry LR. A new nonoxynol-9 formulation (ACIDFORM) significantly impacts experimental genital chlamydia infection in a mouse model. In: Conference abstracts of International Society for Sexually Transmitted Diseases, Denver, CO, July 11-14. 1999;
  3. Spencer SE, Valentin-Bon IE, Whaley K, Jerse AE. Inhibition of Neisseria gonorrhoeae genital tract infection by leading-candidate topical microbicides in a mouse model. J Infect Dis. 2004;189:140–149
  4. Amaral E, Perdigao A, Souza MH, et al. Vaginal safety after use of a bioadhesive, acid-buffering, microbicidal contraceptive gel (ACIDFORM) and a 2% nonoxynol-9 product. Contraception. 2006;73:542–547
  5. Amaral E, Faundes A, Zaneveld L, Waller D, Garg S. Study of the Vaginal Tolerance of ACIDFORM, an acid-buffering bioadhesive gel. Contraception. 1999;60:361–366
  6. Williams DL, Newman DR, Ballagh SA, et al. Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to K-Y jelly used with a diaphragm. Sex Transm Dis. 2007;34:977–984
  7. Moench TR, Chipato T, Padian NS. Preventing disease by protecting the cervix: the unexplored promise of internal vaginal barrier devices. AIDS. 2001;15:1–8
  8. Padian NS, van der Straten A, Ramjee G, et al. Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomized controlled trial. Lancet. 2007;370:251–261
  9. WHO/CONRAD . Manual for the standardization of colposcopy for the evaluation of vaginally administered products, Update 2000. Geneva, Switzerland: CONRAD and the World Health Organization; 2000;
  10. Hooton TM, Scholes D, Hughes JP, et al. A prospective study of risk factors for symptomatic urinary tract infection in young women. N Engl J Med. 1996;335:468–474
  11. Strom DL, Collins M, West SL, Kreisberg J, Weller S. Sexual activity, contraceptive use, and other risk factors for symptomatic and asymptomatic bacteriuria. A case-control study. Ann Intern Med. 1987;107:816–823
  12. Vessey MP, Metcalfe MA, McPherson K, Yeates D. Urinary tract infection in relation to diaphragm use and obesity. Int J Epidemiol. 1987;16(3):441–444
  13. Low-Beer N, Gabe R, McCormack S, Kitchen VS, Lacey CJ, Nunn AJ. Dextrin sulfate as a vaginal microbicide: Randomized, double-blind, placebo-controlled trial including healthy female volunteers and their male partners. JAIDS. 2002;31:391–398
  14. van de Wijgert J, Fullem A, Kelly C, et al. Phase 1 Trial of the topical microbicide BufferGel: Safety results from four international sites. JAIDS. 2001;26:21–27
  15. Elias CJ, Coggins C, Alvarez F, et al. Colposcopic evaluation of a vaginal formulation of iota-carrageenan gel. Contraception. 1997;56:387–389
  16. Van Damme L, Wright A, Depraetere K, et al. A Phase I study of a novel potential intravaginal microbicide, PRO 2000, in healthy sexually inactive women. Sex Transm Inf. 2000;76:126–130
  17. Kreiss J, Ngugi E, Holmes K, et al. Efficacy of nonoxynol 9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes. JAMA. 1992;268:477–482
  18. Niruthisard S, Roddy RE, Chutivongse S. The effects of frequent nonoxynol-9 use on the vaginal and cervical mucosa. Sex Transm Dis. 1991;18:176–179
  19. Roddy RE, Cordero M, Cordero C, et al. A dosing study of nonoxynol-9 and genital irritation. Int J STD AIDS. 1993;4:165–170
  20. Stafford MK, Cain D, Rosenstein I, et al. A placebo-controlled, double-blind prospective study in healthy female volunteers of dextrin sulphate gel: a novel potential intravaginal virucide. JAIDS. 1997;14:213–218
  21. O'Neill E, Reeves MF, Creinin MD. Baseline colposcopic findings in women entering studies on female vaginal products. Contraception. 2008;78:162–166
  22. Fichorova RN, Tucker L, Anderson DJ. The molecular basis of Nonoxynol-9 induced vaginal inflammation and its possible relevance to Human Immunodeficiency Virus Type 1 transmission. J. Infect Dis. 2001;184:418–428
  23. Keller MJ, Guzman E, Hazrati E, et al. Herold B. PRO 2000 elicits a decline in genital tract immune mediators without compromising intrinsic antimicrobial activity. AIDS. 2007;21:467–475
  24. Schwartz J, Mauck C, Lai J, et al. Fourteen-day safety and acceptability study of 6% cellulose sulfate gel: a randomized double-blind Phase I safety study. Contraception. 2006;74:133–140
  25. Karim S, Colleti A, Richardson B, et al. Safety and effectiveness of vaginal microbicides BufferGel and 0.5% PRO 2000/5 gel for the prevention of HIV infection in women: Results of the HPTN 035 trial. In: 16th Conference on Retroviruses and Opportunistic Infections, Montreal, Canada. 2007;

PII: S0010-7824(09)00457-0

doi: 10.1016/j.contraception.2009.10.011

Contraception
Volume 81, Issue 3 , Pages 232-239 , March 2010