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condom female - dịch
condom female - dịch
261–267
Abstract
Objectives: New designs of female condoms have been developed to lower cost and/or improve acceptability. To secure regulatory
approvals, clinical studies are required to verify performance. We aimed to assess the functional performance and safety of two new female
condom types — Velvet and Cupid2 female condom — against the existing FC2 female condom.
Study design: This was a three-period crossover, randomized noninferiority clinical trial with 300 women randomized to condom-type
order in one South African site. Primary end points were total clinical failure and total female condom failure. Noninferiority of component
modes, clinical breakage, nonclinical breakage, slippage, misdirection and invagination were also determined. Safety data were also
assessed for each female condom. Participants were asked to use five of each female condom type and to collect information on use in a
condom diary at home and were interviewed after use of each type. Frequencies and percentages were calculated by condom type for each
failure mode, and differences in performance of the three female condoms using FC2 as reference, with 95% confidence intervals, were
estimated using generalized estimating equation models.
Results: A total of 282 (94%) participants completed follow-up, using at least one condom of each type. Total clinical failure (clinical
breakage, invagination, misdirection, slippage) was b5% for all female condoms: FC2 (4.50%), Cupid2 (4.79%) and Velvet (3.93%).
Noninferiority was demonstrated for all condom failure modes for the two new female condoms with respect to FC2, within the margin of
3% difference in mean failure, at the 5% significance level.
Conclusion: Noninferiority for the two new female condoms was demonstrated with respect to the marketed FC2. These data are used to
support manufacturer dossiers for World Health Organization (WHO)/United Nations Population Fund (UNFPA) prequalification.
Implications: Data from this study have been submitted to WHO/UNFPA and will contribute to the prequalification submission
requirements for the Cupid2 and Velvet female condoms. © 2015 Elsevier Inc. All rights reserved.
☆
There are no conflicts of interest known to the authors.
☆☆
262 M. Beksinska et al. / Contraception 92 (2015) 261–267
This study wasfunded by theUniversal Access to Female reproductive health technologies having the potential to
CondomsJoint Programme, The William and Flora Hewlett Foundation, expand choice in reproductive health and family planning
and Cupid Ltd.
★ programs, add value to the method mix and respond to the
This trial is registered on the South African Clinical Trials needs of a range of clients [4].
database DOH-27-0113-4272. Several new female condom products, in the final stages
⁎ Corresponding author at: MatCH Research (Maternal, Adolescent of development or recently available, aim to reduce unit
and Child Health Research), Department of Obstetrics and Gynaecology,
cost and/or improve acceptability [5]. The first female
Faculty of Health Sciences, University of the Witwatersrand, 34 Essex
Terrace, Westville, Durban 3629, South Africa. condom (FC1) made by the Female Health Company
E-mail address: mags.beksinska@lshtm.ac.uk (M. Beksinska). (FHC) was approved by the US Food and Drug
Administration (USFDA) in 1993. The FHC ceased
http://dx.doi.org/10.1016/j.contraception.2015.05.008 0010- production of the polyurethane FC1 in 2009 and replaced it
7824/© 2015 Elsevier Inc. All rights reserved.
with a similarly designed synthetic latex product called
1. Introduction FC2. Classified as class III medical devices by the USFDA,
the regulatory process for female condoms is more
Like male condoms, female condoms should provide a
complex than for male condoms. This was compounded by
mechanical barrier against unplanned pregnancy and most
the lack of an international standard until 2011 to verify the
sexually transmitted infections (STIs) including HIV [1].
quality of new female condom devices. To secure
Although female condom distribution continues to increase
regulatory approvals, including World Health Organization
globally, increasing from 25 million units in 2007 to over
(WHO)/United Nations Population Fund (UNFPA)
60 million units in 2012 [2], distribution remains
prequalification, manufacturers must conduct clinical
significantly lower compared to male condoms, accounting
studies to verify the performance of new female condom
for only
designs. Two female condoms (FC2 and Cupid) are now
Box 1
prequalified based on the results of clinical noninferiority
Description of study products studies [6,7]. Condom functional performance studies
typically collect detailed data on small numbers of condom
uses (5–10 uses) over a short period of time (4–6 weeks).
Feature FC2 The objectives of this study
Velvet were to assess functional
Cupid2
performance, safety and acceptability of the Velvet and
Cupid2® female condoms as compared to the FC2 control
device. We report here on performance and safety data;
acceptability data will be reported elsewhere.
10 14 (5)
11 55 (19.5)
12 204 (72.3)
Health/Medical 1 (0.4)
Office 4 (1.4)
Sales 2 (0.7)
Student 53 (18.8)
Teacher/Lecturer 1 (0.4)
Volunteer 1 (0.4)
6–10 y 80 (28.4)
2 71 (25.2)
3 or more 46 (16.3)
completedthestudy(94%),with each womanusing at The mean age of participants was 27.4, and the
leastone condom of each of the three female condom majority (96.8%) had 10 years or more of schooling
types. These women comprise the main analysis (Table 1). Almost a fifth (18.8%) were students, and just
population. The study over half (56.7%) were
flowchartisshowninFig.1.Therewereonlythreewomenwho unemployed (Table 1). Most participants were not married
did not return for any follow-up, eight came for one or living with their partners (77.6%). The majority of
follow-up visit and seven for two follow-up visits. participants (98.9%) had ever used male condoms, while
266 M. Beksinska et al. / Contraception 92 (2015) 261–267
just over a fifth (22%) had ever used female condoms (data There was no evidence of superiority for any of the
not shown). new female condoms with respect to FC2 in any of the
failure modes (95% CIs in Table 2 include the null value;
p values for two-sided superiority tests all greater than .
05).
Intotal,4214condompacketswereopenedand4147female
condoms were used in the study. All three female
condoms had similar rates of nonclinical breakage of 2%.
Rates of invagination, slippage and misdirection were all Overall, the occurrence of adverse events occurred in
under 2%. Noninferiority was demonstrated for total approximately 2% of condom uses. No serious adverse
female condom failure for the two female condoms events were reported. A total of 110 events were recorded
Cupid2 and Velvet with respect to the FC2 within the in 84 condoms. Over two-thirds were reported as very
margin of 3% difference in mean failure, at the 5% slight (69.1%) and mild by the remaining third (30.9%).
significance level (Table 2). The p values in Table 2 No action was taken in any of the 110 events, nor was any
indicate the differences between the test condoms and treatment used. Under half of the events were reported to
FC2foreachfailuremodeInonefailuremode—misdirection— have occurred in men (41.8%; n=46) and over half in
the Cupid2 was significantly different from FC2 with 25 women (58.2%; n=64). Of the 110 events, 55 events
events compared to 16, respectively (p=.026). The occurred with Cupid2 in 38 condoms; 31 events occurred
additional analysis performed with women with complete in 25 FC2 condoms and 24 events occurred in 21 Velvet
or incomplete condom series provided similar results (not condoms. Hence, adverse events were highest in Cupid2.
shown).
M. Beksinska et al. / Contraception 92 (2015) 261–267 267
4. Discussion ⁎ p Value indicates differences between the test condom and FC2.
Clinical breakage Cupid2 1373 0.66 (9) −0.23 (−0.77 to 0.32) (−0.87 to 0.42) 0.493
Velvet 1391 0.59 (8) −0.30 (−0.83 to 0.23) (−0.93 to 0.33) 0.350
Invagination Cupid2 1373 1.03 (14) −0.67 (−1.38 to 0.03) (−1.52 to 0.17) 0.118
Velvet 1391 1.37 (19) −0.34 (−1.08 to 0.41) (−1.22 to 0.55) 0.457
Misdirection Cupid2 1373 1.82 (25) 0.84 (0.26 to 1.71 (0.12 to 1.85) 0.026
Velvet 1391 1.15 (16) 0.18 (0.43 to 0.79) (−0.55 to 0.90) 0.628
Slippage Cupid2 1373 1.47 (20) 0.60 (−0.06 to 1.3) (−0,19 to 1.40) 0.136
Velvet 1391 0.87 (12) 0.00 (−0.58 to 0.56) (−0.68 to 0.67) 0.984
Total clinical failurea Cupid2 1373 4.79 (63) 0.29 (−0.94 to 1.51) (−1.72 to 1.75) 0.699
Velvet 1391 3.93 (54) −0.60 (−1.74 to 0.60) (−1.20 to 0.82) 0.422
Total female condom failure Cupid2 1398 6.69 (94) 0.87 (−1.30 to 1.56) (−1.58 to 1.83) 0.882
Velvet 1406 5.82 (82) 0.19 (−2.23 to 0.54) (−2.50 to 0.80) 0.314
a
Six condoms experienced two failures which are considered as one condom failure for total clinical failure.
268 M. Beksinska et al. / Contraception 92 (2015) 261–267
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Conflicts of interest Contraception 2005;72:366–71.
[15] Joanis C, Beksinska M, Hart C, Tweedy K, Linda J, Smit J. Three
There are no conflicts of interest for all authors during new female condoms: which do South African women prefer?
Contraception 2011;83:248–
the study period.
54,http://dx.doi.org/10.1016/j.contraception.2010.08.002.
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