Contraception 92 (2015) 261 – 267

Original research article

A randomized noninferiority crossover controlled trial of the functional

performance and safety of new female condoms: an evaluation of the
Velvet, Cupid2, and FC2☆,☆☆,★
Mags Beksinska a, b,⁎, Ross Greener a , Immo Kleinschmidt b , Lavanya Pillay a ,
Virginia Maphumulo a , Jennifer Smit a, c
a
MatCH Research (Maternal, Adolescent and Child Health Research), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of
the Witwatersrand, 34 Essex Terrace, Westville, Durban 3629, South Africa
b
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E, UK
c
School of Pharmacy and Pharmacology, Faculty of Health Sciences, University of KwaZulu-Natal, University Road, Chiltern Hills, Westville 3629, South Africa
Received 2 February 2015; revised 1 May 2015; accepted 14 May 2015

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 b 5% 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.

Keywords: Female condom; Function; Barrier methods; Safety

☆
There are no conflicts of interest known to the authors.
1. Introduction
☆☆
This study was funded by the Universal Access to Female Condoms Joint
Programme, The William and Flora Hewlett Foundation, and Cupid Ltd. Like male condoms, female condoms should provide a
★
This trial is registered on the South African Clinical Trials database mechanical barrier against unplanned pregnancy and most
DOH-27-0113-4272. sexually transmitted infections (STIs) including HIV [1].
⁎ Corresponding author at: MatCH Research (Maternal, Adolescent and
Child Health Research), Department of Obstetrics and Gynaecology,
Although female condom distribution continues to increase
Faculty of Health Sciences, University of the Witwatersrand, 34 Essex globally, increasing from 25 million units in 2007 to over 60
Terrace, Westville, Durban 3629, South Africa. million units in 2012 [2], distribution remains significantly
E-mail address: mags.beksinska@lshtm.ac.uk (M. Beksinska). lower compared to male condoms, accounting for only
http://dx.doi.org/10.1016/j.contraception.2015.05.008
0010-7824/© 2015 Elsevier Inc. All rights reserved.
262 M. Beksinska et al. / Contraception 92 (2015) 261–267
Box 1
Description of study products
Feature FC2
Material Synthetic nitrile rubber latex
Length (MM) 170
Internal retention mechanism Flexible inner ring
lubricant Silicone oil
Outer retention mechanism Circular ring
at the open end of the condom
Shelf life (y) 5 5
Other features – Natural and flavored varieties
Manufacturer Female Health Company, USA
Approvals USFDA, WHO/UNFPA
0.19% of global condom procurement [3]. In 2011, the
female condom was identified by the Reproductive Health
Supplies Coalition 1 as one of several underused reproductive
health technologies having the potential to expand choice in
reproductive health and family planning programs, add value
to the method mix and respond to the needs of a range of
clients [4].
Several new female condom products, in the final stages
of development or recently available, aim to reduce unit cost
and/or improve acceptability [5]. The first female condom
(FC1) made by the Female Health Company (FHC) was
approved by the US Food and Drug Administration
(USFDA) in 1993. The FHC ceased production of the
polyurethane FC1 in 2009 and replaced it with a similarly
designed synthetic latex product called FC2. Classified as
class III medical devices by the USFDA, the regulatory
process for female condoms is more complex than for male
condoms. This was compounded by the lack of an
international standard until 2011 to verify the quality of
new female condom devices. To secure regulatory approvals,
including World Health Organization (WHO)/United Na-
tions Population Fund (UNFPA) prequalification, manufac-
turers must conduct clinical studies to verify the performance
of new female condom designs. Two female condoms (FC2
and Cupid) are now prequalified based on the results of
1 Women were recruited from an urban reproductive health clinic
A global partnership of public, private and nongovernmental
organizations. Its aim is to ensure that all people in low- and middle-
income countries can choose, obtain and use the supplies and appropriate
services they need to safeguard their reproductive health.
Velvet Cupid2
Natural rubber latex Natural rubber latex
170 125
Flexible inner ring Medical grade sponge
Silicone oil Silicone oil
Circular ring Octagonal outer frame
3
Natural and pink color,
vanilla scented variety
HLL Lifecare, India Cupid Ltd, India
India Drug Control Authority India Drug Control Authority,
CE Mark of the EU
clinical noninferiority 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). The objectives of this study were to assess
functional 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.
2. Materials and methods
2.1. Study design
This was a three-period, randomized noninferiority crossover
clinical trial to compare device function, safety and acceptability
of two new female condom types with the currently available
FC2 as the control device. Of the two available prequalified
female condoms, FC2 was chosen as the control as there are
more clinical data available on FC2 and its functional
performance is well documented [6–10]. Practically, the trial
could not be blinded as all three condom designs are quite
distinct, each requiring product specific training for correct use.
The target population was 300 sexually active women in
Durban, South Africa. The participants were similar in profile
and recruited from the same site which was used to establish the
comparative performance of the reference condom (FC2).
in Durban. The study was conducted between August 2013 and
April 2014. Potential participants had to be at least 18 years of
age and no older than 45, with no known allergies to the study
 M. Beksinska et al. / Contraception 92 (2015) 261–267
products (latex, synthetic latex, polyurethane), using a reliable,
nonbarrier method of contraception, and free of STIs, as
determined by pelvic examination and use of a syndromic
diagnostic tool. Pregnant women (according to urine pregnancy
test) were excluded. Participants were required to be sexually
active and monogamous and could not be practicing sex
workers. Since take-home condom logs were used to gather
data, participants were also required to be literate. Participants
read and signed an informed consent form prior to screening and
enrolment. In this study, each woman was asked to use five of
each of the three female condom types and to complete a
condom log at home after each condom use. After completing
use of each condom type, they were asked to return to the clinic
to be interviewed about their experiences and the condom logs
were reviewed.
2.2. Study products
The three study female condoms are described in Box 1.
Each female condom product was shipped by the
manufacturer to FHI360 for quality assurance testing to
ensure that study products were of the quality specified by the
manufacturer and met International Standards Organization
(ISO) Standard 25841-2011 [8].
2.3. Ethical considerations
This research study followed the CONSORT guidelines
for the reporting of trials and is registered on the South
African Clinical Trials Database DOH-27-0113-4272. This
protocol and related documents were reviewed and approved
by the Human Research Ethics Committee of the University
of the Witwatersrand, Johannesburg, South Africa, prior to
study initiation and enrollment of participants (M120522).
The study was additionally approved by the provincial,
district and local Departments of Health in KwaZulu-Natal
Province. The consent process, all questionnaires and
condom use logs used were written and conducted in a
language understandable to participants. Male partners were
informed of the study by the participants through use of a
fact sheet which explained the purpose of the study, provided
information on the study products and on their role as the
partner in the research.
2.4. Primary study objectives and end points
The primary objective of this research was to compare the
functional performance of three female condom types. The
primary noninferiority end points were self-reported total
clinical failure and total female condom failure. Their
component events, clinical breakage, nonclinical breakage,
total breakage, slippage, misdirection and invagination, were
assessed as well. Safety and acceptability data were also
collected. Female condom failure events (modes) are
recognized by the WHO and other regulatory agencies;
definitions of each failure mode analyzed are as follows [9].
In the risk assessment of the three female condoms used in
this study, no other failure modes were identified.
263
• Clinical breakage: breakage during sexual intercourse
or during withdrawal of the female condom from the
vagina. Clinical breakage has potential adverse clinical
consequences.
• Nonclinical breakage: breakage noticed before inter-
course or occurring after withdrawal of the condom
from the vagina. Nonclinical breakage is without
potential adverse clinical consequences.
• Total breakage: the sum of all female condom
breakages at any time before, during or after sexual
intercourse, and includes both clinical breakages and
nonclinical breakages
• Slippage: when a female condom slips completely out
of the vagina during sexual intercourse
• Misdirection: vaginal penetration whereby the penis is
inserted between the female condom and the vaginal
wall
• Invagination: when the external retention feature of the
female condom is partially or fully pushed into the
vagina during sexual intercourse
• Total clinical failure: the sum of female condoms that
clinically break or slip, or are associated with
misdirection, invagination or any additional failure
mode(s) identified in the risk assessment, which result
in reduction of the female condom-protective function
• Total female condom failure: a female condom for
which a nonclinical breakage, clinical breakage or
slippage occurs, or is associated with misdirection,
invagination or any additional failure modes(s)
identified in the risk assessment
2.5. Secondary study objectives and end points
Secondary objectives were to assess the safety and
acceptability of each of the female condom types. Safety
of each device was measured and evaluated according to
number, severity, relatedness and duration of adverse events.
Standard acceptability measures were collected, and these
data will be reported elsewhere.
2.6. Randomization and concealment
Each of the 300 women was allocated the three types of
condoms in random order. A Williams design [10] was used
to generate the six possible sequences to which women could
be allocated. This ensured that carryover effects from the use
of one condom type to the following condom type were
balanced. To ensure balance of the six sequences, block
randomization was used [11] with randomly permutated
block sizes of 6 and 12, to conceal the next randomization
sequence. Overall, each of the sequences occurred 50 times
to give the 300 allocations.
In order to devise a simple and effective method of
concealment, we used scratch cards, containing the allocated
treatment sequence per participant, where each code for a
given female condom type was concealed beneath a separate
foil square. On each study visit, research staff would remove
264 M. Beksinska et al. / Contraception 92 (2015) 261–267
Fig. 1. CONSORT flowchart.
(scratch) the foil corresponding to the visit number printed
above the square, thereby revealing the next visit allocation
in the sequence. The development and use of the cards is
reported elsewhere [12].
2.7. Sample size
We calculated the power to demonstrate noninferiority
obtained for different sample sizes, starting with a minimum
of 200 women completing the study recommended by ISO
25841 on female condom functionality studies of acute
failure events based on self-reports [8]. We assumed a total
failure rate of 4% for the FC2 as reported from past research
[6,7, 13–15], and a correlation of repeated measures (condom
events) within participants of 0.15, as reported for male
condoms [16]. Using 3% as a (clinically determined) margin
of noninferiority and a significance level of 5% for the
hypothesis of noninferiority, 250 women completing the
study would provide 98% power. We expected a noncomple-
tion rate of up to 15% and increased the sample size to 300.
2.8. Statistical methods
The main analysis for primary and secondary end points
(condom failure events) was a comparison of reported failure
rates of new female condoms with FC2 among the subset of
participants who provided relevant follow-up data on at least
one condom of each type.
The hypothesis for the primary end points, total clinical
failure and total female condom failure and their component
failure events, was that each of the new condoms Velvet and
Cupid2 was “noninferior” to FC2 (the reference female
condom).
To demonstrate noninferiority, the upper limit of the
two-sided 90% confidence interval (CI), (equivalent to
one-sided 95% CI) for the difference in the occurrence of
failure events (new female condom — FC2) was required to
be below 3.0%, that is, demonstration that failure rate
differences were below 3% [8]. If noninferiority was
demonstrated and the difference was less than zero, that is,
the new condom had lower failure rates, the hypothesis of
superiority was tested at 5% level of significance.
Primary end points were analyzed using generalized
estimating equations assuming a binomial distribution of the
response, an exchangeable correlation matrix and an identity
link function. Type of condom was included in the model at
the couple-use level defining couples as clusters, to take into
account correlation of responses for repeated observations
for the same couple.
3. Results
Data were collected between August 2013 and April 2014.
A total of 305 women were recruited and screened from the
client population of the reproductive health clinic. Three
hundred women were enrolled in the study. In total, 282 women
completed the study (94%), with each woman using at least one
condom of each of the three female condom types. These
women comprise the main analysis population. The study
flowchart is shown in Fig. 1. There were only three women who
did not return for any follow-up, eight came for one follow-up
visit and seven for two follow-up visits.
The mean age of participants was 27.4, and the majority
(96.8%) had 10 years or more of schooling (Table 1). Almost a
fifth (18.8%) were students, and just over half (56.7%) were
 M. Beksinska et al. / Contraception 92 (2015) 261–267 265

Table 1
Baseline sociodemographic characteristics of the main analysis population (N=282)
Characteristic
Age (y) Mean (SD) 27.4 (5.78)
Min–Max 18–45
Ethnic group, n (%) Black 282 (100)
Completed years of school, n (%) 8 6 (2.1)
9 3 (1.1)
10 14 (5)
11 55 (19.5)
12 204 (72.3)
Primary occupation, n (%) None/Unemployed 160 (56.7)
Self-employed + other 5 (1.7)
Unskilled labor 54 (19.1)
Health/Medical 1 (0.4)
Office 4 (1.4)
Public service/government 1 (0.4)
Sales 2 (0.7)
Student 53 (18.8)
Teacher/Lecturer 1 (0.4)
Volunteer 1 (0.4)
Marital status, n (%) Married or living together 62 (22)
Not married and not living together 219 (77.6)
Married and not living together 1 (0.4)
Length of relationship with spouse/partner, n (%) Less than 1 y 6 (2.1)
1–5 y 161 (57.1)
6–10 y 80 (28.4)
More than 10 y 35 (12.4)
Number of living children, n (%) 0 27 (9.6)
1 138 (48.9)
2 71 (25.2)
3 or more 46 (16.3)

unemployed (Table 1). Most participants were not married or
living with their partners (77.6%). The majority of participants
(98.9%) had ever used male condoms, while just over a fifth
(22%) had ever used female condoms (data not shown).
In total, 4214 condom packets were opened and 4147 female
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 under 2%.
Noninferiority was demonstrated for total female condom
failure for the two female condoms Cupid2 and Velvet with
respect to the FC2 within the margin of 3% difference in mean
failure, at the 5% significance level (Table 2). The p values in
Table 2 indicate the differences between the test condoms and
FC2 for each failure mode In one failure mode — misdirection —
the Cupid2 was significantly different from FC2 with 25 events
compared to 16, respectively (p=.026). The additional analysis
performed with women with complete or incomplete condom
series provided similar results (not shown).
There was no evidence of superiority for any of the 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).
Overall, the occurrence of adverse events occurred in
approximately 2% of condom uses. No serious adverse
events were reported. A total of 110 events were recorded in
84 condoms. Over two-thirds were reported as very slight
(69.1%) and mild by the remaining third (30.9%). No action
was taken in any of the 110 events, nor was any treatment
used. Under half of the events were reported to have
occurred in men (41.8%; n= 46) and over half in women
(58.2%; n= 64). Of the 110 events, 55 events occurred with
Cupid2 in 38 condoms; 31 events occurred in 25 FC2 condoms
and 24 events occurred in 21 Velvet condoms. Hence, adverse
events were highest in Cupid2.
4. Discussion
The two new female condoms (Cupid2 and Velvet)
evaluated in this study are noninferior to the reference
condom (FC2) within a margin of 3% failure for all the
functional parameters. The reporting of adverse events was
1% higher than the rates reported in a previous study [7],
which included the same control FC2 and the currently
available Cupid. In this study, adverse events for Cupid2
were the highest of the three condoms evaluated. The FC2 is
made of synthetic latex and therefore does not expose users
to the proteins in natural rubber latex that can cause latex
allergies. The Velvet and Cupid2 are made of latex, and so it
would be expected that these condoms may cause more
irritation than those made of synthetic latex. The outer ring/
frame of the Cupid2 is also more rigid compared to velvet
and FC2 and may have resulted in more discomfort in some
users.
266 M. Beksinska et al. / Contraception 92 (2015) 261–267

Table 2
Mean failure and failure difference of Cupid2, Velvet in relation to FC2, with two-sided 90% CIs for noninferiority hypothesis at α=5% and two-sided 95% CIs
for superiority hypothesis, for the main analysis population
Condom function Condom Condoms, Mean Failure difference (%) p-Value⁎
type n failure
Difference with FC2 90% CI 95% CI
(n=282), (%) n
Nonclinical breakage Cupid2 1397 2.2 (31) − 0.15 (− 1.04 to 0.75) (− 1.22 to 0.92) .798
Velvet 1406 1.98 (28) − 0.37 (− 1.24 to 0.51) (− 1.41 to 0.68) .489
FC2 1410 2.35 (33) (Ref) – – –
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
FC2 1383 0.89 (12) (Ref) – – –
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
FC2 1383 1.71 (23) (Ref) – –
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
FC2 1383 0.98 (13) (Ref) – – –
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
FC2 1383 0.87 (12) (Ref) – – –
Total clinical failure a 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
FC2 1383 4.50 (60) (Ref) – – –
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
FC2 1410 6.66 (93) (Ref) – – –
a
Six condoms experienced two failures which are considered as one condom failure for total clinical failure.
⁎ p Value indicates differences between the test condom and FC2.

The total clinical failure, total female condom failure and
component failure rates reported are expected and consistent
with findings from earlier, similarly conducted studies [6,7,
13–15]. Unlike male condoms, new female condoms are
required to provide evidence of functional noninferiority
with respect to the marketed FC2. 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.
Evidence for the effect of choice of method on increased
uptake of contraceptive methods is limited; however, a
systematic review of the evidence in 2006 supports the
argument that increased contraceptive choice for women is
associated with increased uptake and better health outcomes
(such as lower pregnancy rates and fewer STIs) [17]. Further,
women continue use of their chosen contraceptives to a
greater degree than those denied a choice of method [18].
Access to a variety of female condom types could improve
choice for women in need of a contraceptive method or for
dual protection against pregnancy and infection.
The availability of new female condom products will
provide donors and users with more options and has potential
to reduce unit price of devices [4]. The Reproductive Health
Supplies Coalition has published information comparing
different female condom unit costs to the donor funded
public sector, indicating that when Cupid female condom
was prequalified in 2012, it was sold at a lower price per unit
compared to FC2 [4].
The current public sector price of the two available
prequalified female condoms (FC2 and Cupid) are still much
higher than most developing country programs can support,
with female condoms costing approximately 20 times more
to produce compared to male condoms [19]. If new designs
become available, increased choice and competition may
lead to a price reduction and increased distribution of female
condoms globally.
5. Limitations
A limitation of this study was that it was not possible to
blind the participants and research staff to the products as
they are all quite different. Allocation concealment was used
to ensure that this limitation was minimized. This study was
based exclusively on self-reported measures of condom use.
To validate condom function more accurately, the use of
PSA would provide stronger evidence if failures reported led
to exposure to semen and this would supplement, and
possibly partly displace, observations and records made by
the participants.
Conflicts of interest
There are no conflicts of interest for all authors during the
study period.
 M. Beksinska et al. / Contraception 92 (2015) 261–267
Acknowledgments
We thank all research nurses, interviewers and data entry
staff who collected and entered the data. We thank all
participants who gave their time to participate in the trial.
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