The U.S. Agency for International Development (USAID) recently provided a limited supply of female condoms to 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.
2. Farr G, Gabelnick H, Sturgen K, et al. Contraceptive efficacy and acceptability of the female condom. Am J Pub Health 1994; 84:1960-64.
3. Feldblum P, Joanis C. Modern Barrier Methods: Effective Contraception and Disease Prevention. Durham: Family Health International, 1994.
4. The Female Health Company, Division of Wisconsin Pharmacal. Reality Female Condom: An Alternative for Women. Chicago: Wisconsin Pharmacal, 1994.
5. 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.
6. 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.
7. 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.
Click to select preferred language, if other than English: French | Spanish.
