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The U.S. Agency for International Development (USAID) recently
provided a limited supply of female condomsto family planning programs in 22 countries.
USAID will evaluate whether to continue supplying them. As part of the introduction of
this method, FHI prepared an information packet for family planning managers. The
following is a concise overview statement and a question and answer sheet that were
included in the packet.
The female condom is a barrier method of contraception that is highly effective in
preventing pregnancy, provided it is used correctly and consistently. Research on how well
this relatively new method protects against sexually transmitted diseases (STDs) remains
to be done. Its ability to protect against STDs, including HIV, is speculative but
promising.
This female-controlled barrier method may be especially useful for women at risk of STDs
who have difficulty convincing their male partners to use latex condoms. The female condom
is marketed as Reality in North America and Femidom in Europe. The U.S. Food and Drug
Administration (FDA) approved it for marketing in the United States in 1993.
Stronger than latex
Female condoms are made of a polyurethane plastic that is sturdier than male latex
condoms, potentially offering less frequent breakage, improved comfort, and longer shelf
life, even under unfavorable storage conditions.
This device consists of a soft, loose-fitting sheath and two flexible polyurethane rings
at each end. One ring is at the closed end of the sheath and serves as an insertion
mechanism and anchor inside the vagina. The outer ring forms the external edge of the
device and remains outside the vagina after insertion, thus providing protection to the
labia and the base of the penis during intercourse. This design may reduce the potential
for transfer of infectious organisms between sex partners, particularly genital ulcer
diseases.
Unlike latex male condoms, which are weakened by using oil-based lubricants, the female
condom may be used with any type of lubricant without compromising its strength. It is
prelubricated, but more lubricant may be added by users.
One size, one-time use
While this device is currently approved for a single use only, studies are under way to
determine if the female condom can be cleaned and used more than once without lowering
efficacy or compromising safety. Fitting by a health professional is not required as the
device does not have to be precisely placed over the cervix.
Contraceptive effectiveness
In its ability to prevent pregnancy, the female condom is similar to other barrier
methods, such as the diaphragm and male latex condom. To determine contraceptive
effectiveness, Family Health International (FHI) and the Contraceptive Research and
Development Program (CONRAD) conducted a clinical trial of the female condom in nine
centers -- six in the United States and three in Latin America. For the 377 women entered
in the trial, the six-month life-table pregnancy rate was 15.1 per 100 women (12.4 per 100
in the United States and 22.2 per 100 in Latin American centers). This typical failure
rate in the U.S. centers was similar to six-month failure rates for the diaphragm, vaginal
sponge and the cervical cap during typical use.
What if the device is used correctly for every act of intercourse? In the FHI/CONRAD
collaborative study, the six-month failure rate during perfect use of the female condom
was 4.3 per 100 women. Comparison of the U.S. data with data from other studies indicates
that the probability of failure during perfect use for the female condom is similar to the
male condom and the diaphragm, and slightly lower than that for the cervical cap and the
sponge.
Prevention of STDs and AIDS
Laboratory studies have found that the female condom is impermeable to various STD
organisms, including HIV and other viruses. Only one study involving human use has been
done to evaluate the prophylactic properties of the female condom. In it, 104 women who
had been previously diagnosed and treated for recurrent vaginal trichomoniasis were
assigned to a group using the female condom or to a control group (volunteers who
indicated they would not use the condom). Each group was followed for a 45-day period of
their usual sexual activity. Reinfection with trichomonas occurred in seven of the 50
controls (14 percent) and five of the 34 non-perfect users (14.7 percent), but none of the
20 perfect users of the female condom. FHI and the World Health Organization will conduct
at least one study of female condom use and cervical infection. Until then, the efficacy
of using female condoms for STD prevention remains speculative, but promising.
The U.S. FDA recommends using the male latex condom as a highly effective preventive
measure against STDs, but using the female condom as an alternative when the male partner
will not use a condom.
Advantages and disadvantages
This unique device offers several advantages:
- The female condom does not constrict the penis, as do latex male condoms. As a result,
sensitivity for males may be better. Similarly, females have reported minimal loss of
sensation while using the product. Unlike latex, the polyurethane material in the female
condom allows the transfer of body heat, which may improve sensation.
- Since the female condom covers much of the external female genitalia, it provides a more
extensive barrier and may offer somewhat greater protection than male condoms against
genital ulcer diseases, such as herpes and chancroid.
- The device is female-controlled. For a woman at risk of STD, the female condom provides
a prophylactic option should her partner refuse to use a male condom.
- Preferences for lubrication vary. The female condom can be used with any type of
lubricant without compromising the integrity of the device, which is an advantage in
countries where water-based lubricants are hard to obtain.
- Some women find the female condom is more convenient to use than other female barrier
methods. It can be used without a spermicide. Like the diaphragm, cervical cap and sponge,
it can be inserted well before intercourse, although it may not be comfortable to do so.
- As with any contraceptive method, the female condom has disadvantages:
- The female condom is relatively expensive. The average price in the United States is
about $2.50 each, about five times the price of a male latex condom. (If the device can be
used safely and effectively more than once, its cost to a user would be lower.)
- It covers the external female genitalia. While that feature may offer better STD
protection, many couples find this unappealing. It is a commonly cited reason for
discontinuing use of the device.
- Some users complain that it is noisy during use. During vigorous use, it may be pushed
into the vagina.
- Though very rare, female condom breakage was reported in about 1 percent of devices used
in one clinical trial. (This is lower than the expected breakage rate for latex condoms,
between 2 and 5 percent of devices used.)
What people like or do not like
Over six years, FHI has evaluated the acceptability of the female condom among diverse
populations. The most frequent complaints were not liking the inner ring and movement of
the device during use. There were few insertion-related complaints, although some women
said that it took more than one attempt to get used to inserting the condom. Many women
reported that they liked using the device and would recommend it to others.
The appearance and even the concept of this first generation of female condoms is
unfamiliar to most people. Perceptions may change with time as people become more
accustomed to the device.
Sources
- Bounds W, Guillebaud J, Newman GB. Female condom
(Femidom). A clinical study of its use-effectiveness and patient acceptability. Br J
Fam Plann 1992; 18:36-41.
- Farr G, Gabelnick H, Sturgen K, et al. Contraceptive
efficacy and acceptability of the female condom. Am J Pub Health 1994; 84:1960-64.
- Feldblum P, Joanis C. Modern Barrier Methods:
Effective Contraception and Disease Prevention. Durham: Family Health International,
1994.
- The Female Health Company, Division of Wisconsin
Pharmacal. Reality Female Condom: An Alternative for Women. Chicago: Wisconsin
Pharmacal, 1994.
- Ford N, Mathie E. The acceptability and experience of
the female condom, Femidom among family planning clinic attenders. Br J Fam Plann
1993; 19:187-92.
- Soper DC, Shoupe D, Shangold GA, et al. Prevention of
vaginal trichomoniasis by compliant use of the female condom. Sex Transm Dis 1993;
20:137-39.
- Trussell J, Sturgen K, Stricker J, et al. Comparative
contraceptive efficacy of the female condom and other barrier methods. Fam Plann
Perspect 1994; 26:66-72.
For more information, visit Family Health International's Website at www.fhi.org
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