A randomised trial has shown that three new models of female
condom are non-inferior to the established model, leading the authors to
suggest that the new products could be made more widely available, increasing
the range of prevention options available to women. An
open-access article reporting on breakage and slippage is published in the
September issue of Lancet Global Health, with
acceptability data having been presented to a conference earlier in the year.
The first model of female condom, FC1, sometimes marketed as
Femidom or Reality, was introduced in 1993. An improved model that is softer
and less noisy, as well as much cheaper to produce – known as FC2 – was
approved by United Nations agencies in 2007 and US regulators in 2009.
But female condoms remain under-used, with international
donors distributing around 140 male condoms for each female condom that they
provide. A number of barriers have been identified – cost (around $0.60 each,
compared to $0.03 for a male condom); few studies to demonstrate their
effectiveness against infections; minimal
support from policy makers; inconsistent distribution and promotion; low
awareness amongst women and their partners; and little variety in the design of
a product that can be difficult to use at first.
Responding to the last issue, several new models have been
developed, with this study evaluating the Woman’s Condom
(developed by the non-profit organization PATH), the VA wow condom (Medtech
Products, India) and the Cupid female condom (Cupid, India), in comparison with
FC2 as the ‘standard of care’.
While each has some unique design features, there are many
similarities. Each comprises a soft, flexible sheath that lines the vagina and
may partially cover the external genitalia. In order to hold the condom in
place, devices variously have an internal ring, a foam sponge or small dots of
soft foam which gently adhere to the interior of the vagina. To make insertion
easier, the Woman’s Condom is held together by a rounded cap which dissolves once
it is put in place. Each device has some sort of external ring or frame which
prevents the condom from being pushed inside the vagina and which aids removal.
The different condoms are made variously of natural latex,
synthetic rubber or polyurethane. With one exception, all are pre-lubricated.
Researchers recruited 272 women in Durban, South Africa and
300 women in Shanghai, China. Participants were generally well educated. Almost
all the Chinese women were living with a partner, whereas only a minority of
the South African women were. While 14% of the South
African women had previously used a female condom, none of the Chinese women
Each woman was asked to use each type of condom five times
each, but was randomised to a group testing the condoms in a different sequence.
Diaries and interviews were used to gather data on failure rates and
This was a ‘non-inferiority’ trial – in other words, the
researchers aimed to verify that the new models were not worse than FC2. Similarly,
FC2 was approved by regulators on the basis of data showing that it was
non-inferior to FC1 in terms of failure.
Regarding condom failure, the researchers asked about the
devices tearing or breaking; slipping out of the vagina; the penis being
inserted between the condom and the vaginal wall; and the external ring or
frame being pushed inside the vagina.
On each measure, rates were low, and generally did not
differ significantly from FC2, with all being found to be non-inferior to FC2
(within a margin of 3%). Overall condoms failed on around 3 in every 100
occasions – 2.9% for FC2, 3.1% for the Woman’s Condom, 2.5% for VA wow and 3.9%
for Cupid. (Similar, and often higher, failure rates have been reported for
Failure rates were similar in South Africa and China, reinforcing the validity of the results.
Less than 1% of women reported adverse events such as
vaginal pain, penile itching or rash.
In terms of acceptability, data are only available from the
South African participants. Individual women expressed different preferences
for different models, and some devices were better rated for some features than
for others, but overall scores were consistent, with all new models at
least as acceptable as FC2.
In terms of feel and sensation, 91.2% of women ‘liked
somewhat’ or ‘liked very much’ the Woman’s Condom, 90.8% did so for Cupid,
88.2% for FC2 and 83.8% for VA wow. Similarly, each scored over 80% for its
appearance; over 85% for its length, lubrication and scent; and over 90% for
In terms of ease of use over 85% of women ‘liked somewhat’
or ‘liked very much’ each model. However, scores for ease of insertion were
lower – over 60% for each device, except for VA wow which scored 48.5%.
The investigators report that manufacturers of the devices
are using these results in their applications to regulatory authorities. The
Cupid condom has been approved (pre-qualified) by the World Health Organization
(WHO) and the United Nations Population Fund (UNFPA). It is already available
in South Africa, Mozambique, Indonesia, India, and other countries, and with a
unit price of $0.35 it is cheaper than FC2.
US investigators are completing analysis of an observational
study assessing the Woman’s Condom effectiveness in preventing pregnancy.
Moreover, the failure rate of the condom will be assessed not only by
self-report, but by testing vaginal samples for prostate-specific antigen (PSA),
a biomarker for exposure to semen. If supportive, these study results may lead
to approval by the Food and Drug Administration (FDA) in the United States, as well as
More data on the products’ effectiveness in preventing
pregnancy and infections may be important in strengthening policy makers’
support for female condoms.
The investigators believe that a greater choice of models
for women and their partners may lead to improved uptake and more consistent
use of female condoms, resulting in fewer infections and unwanted pregnancies.