Abstract
Background
Male and female condom (FC) functional performance failure declines with user experience.
With the recent availability of a wider range of FCs, it is important to know if women
with experience in using one type of FC are more proficient in using another type,
even if the FC design is quite different.
Study design
A randomized, noninferiority crossover clinical trial assessed the function of four
FCs (FC2, Woman's Condom, Cupid and VA w.o.w) among 300 women in Durban, South Africa.
FC functional failure (breakage, slippage, invagination and misdirection) by condom
type and use period was investigated in women using five FCs of each type (20 FC uses
in total).
Results
Of the 5364 condoms used during intercourse by 272 women, 200 clinical failures occurred
in 195 condoms (190 condoms had one failure, and 5 had two failures). Total clinical
failure was comparable across FC types. Of the 195 condoms in which failures occurred,
the number of failures in the first condom use period was 103 (7.7%), decreasing to
43 events (3.2%) in the second, 33 (2.5%) in the third and 16 (1.2%) in the fourth.
Only 2 failures were reported in the 20th use of an FC compared to 29 in the first
use, irrespective of condom type.
Conclusions
FC failure rates decreased markedly after use of the first five condoms regardless
of FC type and continued to fall across the next three use periods.
Implications
FC failure rates decrease over 20 uses, regardless of FC condom type used. The decrease
is higher at the beginning of use, indicating that improvement is greatest after the
first five uses.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to ContraceptionAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- UNFPA, WHO, UNAIDS.
- Latex condom breakage and slippage in a controlled clinical trial.Contraception. 1997; 56: 17-21
- Standardized definitions of failure modes for female condoms. A commentary.Contraception. 2007; 75: 251-255
- Performance of the Reality® polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women.Contraception. 2006; 73: 386-393
- Comparative crossover study of the PATH Woman's Condom and the FC Female Condom®.Contraception. 2008; 78: 465-473
- Practice makes perfect: reduction in female condom failures and user problems with short-term experience in a randomized trial.Contraception. 2012; 86: 127-131
- Female condom and male condom failure among women at high risk of sexually transmitted diseases.Sex Transm Dis. 2005; 32: 35-43
- Female condoms in the pipeline.Reprod Health Matters. 2012; 20: 188-196
- Performance and safety of the second-generation female condom versus the Woman's, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial.Lancet Glob Health. 2013; 1: e146-e152
- Female condoms — Requirements and test methods: ISO 25841:2011(E) Switzerland.
- Using scratch card technology for random allocation concealment.Clin Trials. 2012; 10: 125-130
- Use of the female condom among sex workers in China.Int J Gynecol Obstet. 2003; 81: 233-239
- Short-term acceptability of the PATH Woman's Condom among couples at three sites.Contraception. 2006; 73: 588-593
Article info
Publication history
Published online: September 26, 2014
Accepted:
September 22,
2014
Received in revised form:
August 29,
2014
Received:
May 28,
2014
Footnotes
☆There are no conflicts of interest known to the authors.
☆☆This study was funded by the Universal Access to Female Condoms Joint Programme.
★This trial is registered on the South African Clinical Trials database DOH-27-0113-4271.
Identification
Copyright
© 2014 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
