Female condom technology: New products and regulatory issues

Contraception

Volumn 83, Issue 4, 2011, Pages 316-321

  Beksinska, Mags ^a   Smit, Jenni ^a   Joanis, Carol ^b   Usher Patel, Margaret ^c   Potter, William ^d  

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^b Joanis Consulting   (United States)

^c WORLD HEALTH ORGANIZATION   (Switzerland)

^d Stapleford Scientific Services Ltd   (United Kingdom)

Author keywords

Female condoms; Prototypes; Regulatory process; Standards

Indexed keywords

LATEX; NITRILE; POLYURETHAN;

CONDOM; FEMALE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE COST; HUMAN; QUALITY CONTROL; REVIEW; SEXUALLY TRANSMITTED DISEASE; TECHNOLOGY; UNPLANNED PREGNANCY;

CONDOMS, FEMALE; CONTRACEPTION; FEMALE; HUMANS; MALE;

EID: 79952574690     PISSN: 00107824     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.contraception.2010.07.022     Document Type: Review

References (17)

1. World Health Organization. Female Condom Technical Review Committee report of meeting, 16-18 Jan 2006, Geneva, Switzerland.
2. Beksinska M, Joanis C, Manning J, et al. Standardized definitions of failure modes for female condoms. A commentary. Contraception 2007;75:251-5. (Pubitemid 46385917)
3. Bounds W, Guillebaud J, Newman GB. Female condom (Femidom). A clinical study of its use-effectiveness and patient acceptability. Br J Fam Plann 1992;18:36-41.
4. Farr G, Galbenick H, Sturgen K, et al. Contraceptive efficacy and acceptability of the female condom. AmJ Public Health 1994;84:1960-4.
5. Trussell J. Contraceptive efficacy of the Reality female condom. Contraception 1998;58:147-8.
6. World Health Organization. The female condom: a review. Geneva (Switzerland): World Health Organization; 1997.
7. Beksinska M, Smit J, Mabude Z, Vijayakumar G, Joanis C. Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized cross-over trial among South African women. Contraception 2006;73:386-93. (Pubitemid 43375101)
8. Valappil T, Kelaghan J, Macaluso M, et al. Female and male condom failure among women at high risk of sexually transmitted disease. Sex Transm Dis 2005;32(1):35-43. (Pubitemid 40054159)
9. Leeper MA, Conrady M. Preliminary evaluation of REALITY, a condom for women to wear. Adv Contracep 1989;5:229-35. (Pubitemid 20173983)
10. Vijayakumar G, Mabude Z, Smit J, Beksinska M, Lurie MA. Review of female-condom effectiveness: patterns of use and impact on protected sex acts and STI incidence. Int J STD AIDS 2006;17:652-9. (Pubitemid 44611145)
11. Smit J, Beksinska ME, Mabude Z, Vijayakumar G. Acceptability of the reality polyurethane female condom and a synthetic latex prototype: a randomized cross-over trial among South African women. Contraception 2006;73:394-8. (Pubitemid 43375102)
12. Smita J, Neelam J, Rochelle DY, et al. Comparative acceptability study of the reality female condom and the version 4 of modified Reddy female condom in India. Contraception 2005;72:366-71. (Pubitemid 41503135)
13. Coffey PS, Kilbourne-Brook M, Austin G, Seamans Y, Cohen J. Shortterm acceptability of the PATH Woman's Condom among couples at three sites. Contraception 2006;73:588-93.
14. Schwartz JL, Barnhart K, Creinin MD, et al. Comparative crossover study of the PATH Woman's condom and the FC Female Condom®. Contraception 2008;78:465-73.
15. Hou LY, Qiu HY, Zhao YZ, Zeng XS, Cheng YM. A crossover comparison of two types of female condom. Int J Gynaecol Obstet 2010;108:214-8.
16. http://www.unaids.org/unaids-resources/images/ICC-UNAIDSresources/ FS-condoms.pdf.
17. Mauck CK, Weaver MA, Schwartz JL, Walsh T, Joanis C. Critical next steps for female condom research - report from a workshop. Contraception 2009;79:339-44.