Do they work?

Standard permeability tests have established that the female condom is no more likely to let through pathogens or sperm cells than the male condom. This leads to mathematical modelling which suggests that consistent and correct use of female condoms by an HIV-negative women with an HIV-positive partner, if they have sex twice weekly for a year, could reduce her chance of acquiring HIV by about 90% – similar to the maximum achievable for consistent male condom use (even consistent and correct use does not result in 100% protection with condoms, as the chances of breakage and slippage cannot be eliminated entirely).

Trials in the US and the UK show a pregnancy failure rate of 2.4% when the female condom is used properly, and 12.2% when not used properly and consistently (source: Female Condom Company). That compares to a 2% pregnancy failure rate for properly used 'Kitemark' condoms, rising to up to 15% for improperly used condoms (source: Durex).

There have been very few randomised studies of female condom use. In a US study in 2003,¹ 1442 women attending an STI clinic were randomly assigned to receive free female or male condoms and small-group education on their use. There was a 21% reduction in new STI incidence at subsequent screening in the female condom users, which was almost statistically significant (p = 0.07).

In one study in the late 1990s in Thailand,² sex workers in four cities were randomised into two groups: 255 women were instructed to use male condoms consistently, while 249 women were provided with female condoms as well and had the option of using them if clients did not want to use male condoms. Male condom use was lower in the male/female condom group when compared with the male condom group (88.2 and 97.5%, respectively, p =< 0.001). However, this reduction in male condom use was counterbalanced by the use of female condoms in 12% of all sexual acts in the male/female condom group, contributing to a 17% reduction in the proportion of unprotected sexual acts in this group when compared to the male condom group (5.9% versus 7.1%, though this was not statistically significant [p = 0.16]).

A 2005 study in Madagascar³ enrolled 1000 sex workers and supplied and promoted male condoms for six months. They then supplied female condoms in addition to male condoms for the following six months. The mean proportion of sexual acts that were protected increased from 57% at baseline to 88% at 18-month follow-up. Male condom use at six months was 78%; at 12 months this had dropped to 64% but was more than compensated for by a 19% rate of female condom use. At 18 months 68% of sexual acts involved male condoms and 20% female condoms. The proportion of clients with any STI declined from 49% at six months to 40% at 18 months. However the proportion of sexual acts with primary and non-paying partners that were protected, though increasing from 20% at baseline to 30% at two months, did not increase further.

A large multi-country trial by the WHO³ compared pregnancy rates in 1071 women using male condoms (344 women), female condoms (482 women) or both (131 women) in China, Panama, Nigeria and South Africa. At six months, pregnancy rates were statistically indistinguishable between users of male versus female condoms. Discontinuation rates were interestingly different, however: in China less than 1% of the women using male condoms stopped using them but over 15% of the female condom users did. Conversely in South Africa 78% of women stopped using male condoms in accordance with the study protocol but only 36% of the female condom users.  

An overall survey⁴ of 14 randomised and observational studies of adding-in the female condom to the prevention choices available to women, including the US, Thai and Madagascar studies above, found that eleven studies reported some positive effect on STI incidence, pregnancy or protected sexual acts.

In 2005 Susie Hoffman⁴ reviewed studies of female condoms (primarily FC1) and said that acceptability rates in studies had varied hugely from 37 to 96%.

Positive aspects of the female condom cited in various studies by Hoffman include the fact that it enhanced women’s ability to negotiate and ensure safer sex, the strength and hypoallergenic nature of polyurethane, and that for some couples it enhanced sexual pleasure: for the men, it felt less restrictive and dulled sensitivity less than male condoms. For the women it could be inserted well before sex and so increased spontaneity, and for both it conducted heat better so that sex felt more ‘natural’.

However for a majority of women and couples the overall impression was negative. It was criticised aesthetically for looking ‘weird’, especially in the way the outer ring protruded from the vulva; many women and some men found it uncomfortable; men has insertion difficulties, and one of the most frequent causes of failure was that men ‘aimed wrong’ and inserted their penis between the condom and the vaginal wall rather than inside the condom. It was also noisy: polyurethane is slightly stiffer than latex and makes a crinkling sound.

Theresa Hatzell Hoke of Family Health International cited an early UK study⁵ from 1992 which recruited 106 self-selected women with near-universal experience of male condoms who volunteered to try the Femidom as their sole method of contraception for twelve months. The majority (56%) of women ended up discontinuing Femidom use; only 11 women used it consistently for the whole year, another 16 who indicated they would have continued to use it were forced to discontinue due to supply problems, and four said they would have continued to use it but that their partners disliked it, thus making a maximum of 29% of women who said they found the Femidom acceptable enough to use it as their sole method of contraception, and 25% of couples. There were seven non-intentional pregnancies during the year.