• Summary
• Credits

1. The Long Road of Contraceptive Development
2. Vaginal Rings
3. Transdermal Contraception
4. Contraceptive Implants
5. Combined Injectables
6. Condoms
• Male Condoms
• Female Condoms
7. Fertility Awareness-Based Methods
8. Oral Contraceptives
9. Intrauterine Devices
10. Transcervical Female Sterilization
11. Male Hormonal Contraception
12. Bibliography
13. Web Supplements

• Clinical trials assess effectiveness and safety of new contraceptives
• New low-dose DMPA formulation
• More long-term choices for men

• INFO Project
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• Online Reports
• Upcoming Reports
• POPLINE

Condoms

New Condoms Description: Male condoms—A sheath made of nonlatex materials placed over the penis. Female condoms—a sheath made of latex inserted into the vagina. Stage of development: Some already on the market and others in clinical trials. Effectiveness: Probably similar to other condoms—10 to 15 pregnancies per 100 women per year as typically used. How they work: Cover the cervix or the penis to block sperm from entering the cervical canal. What’s new? Designed to expand variety, encourage use, cause fewer allergies, or cost less than other available barrier methods.

Increasingly, companies are manufacturing male and female condoms in different materials to expand variety and encourage use. Male condoms are being developed in nonlatex varieties, and female condoms, first made of polyurethane, are now being developed in latex form.

While condoms provide the best protection against HIV infection, other new barrier methods in development also may provide some protection, especially when used along with microbicides, when microbicides become available. (See INFO Reports, “Microbicides: New Potential for Protection,” January 2005). These new barrier methods include cervical caps, diaphragm-like devices, and sponges that emphasize comfort and ease of use (see Web Supplement, “Vaginal Barriers”).

Newer forms of male condoms include synthetic nonlatex condoms, which many men prefer. For men who are sensitive or allergic to latex, new condom materials include polyurethane and styrene ethylene butylene styrene (SEBS), a synthetic material known commercially as Tactylon^®.

Synthetic nonlatex male condoms. Polyurethane and SEBS condoms have two advantages over latex condoms. They have a longer shelf life and can be used with oil-based lubricants, which can damage latex condoms (84). Some users also say nonlatex condoms have less odor, fit more comfortably and are less constricting, and transfer body heat better than latex condoms (84). Surveys to confirm these impressions have not been conducted, however.

Polyurethane condoms have been available in the US since 1995 (250). SEBS condoms are not yet marketed (70). The availability of nonlatex condoms in developing countries is limited. A Colombian company, Natural Sensation, has been producing polyurethane condoms since 1993, branded as Unique^® condoms for men and Unisex^® condoms for men and women. These brands are available throughout Latin America (46).

Many studies have examined differences between synthetic nonlatex and latex condoms (45, 54, 84, 190, 234, 245, 255). An analysis of data from 10 comparative studies found that more users preferred synthetic nonlatex condoms and said they would recommend them to others. Several synthetic nonlatex condoms (Durex Avanti, eZ-on, and Tactylon), however, broke or slipped more often during intercourse or withdrawal than latex condoms (84). Despite the greater breakage and slippage rates, most were as effective as latex condoms in preventing pregnancy (84).

Women in focus-group studies say that they want contraceptive barrier methods whose use they could control (97, 186). The only female condom available, however, the FC Female Condom^® (formerly Reality), is made of polyurethane and is too costly for many family planning programs or clients. Several newer female condoms—the FC2, the VA feminine condom, and the PATH Woman’s Condom—are made of less costly materials. They are now in clinical trials.

FC2 Female Condom. The FC2 Female Condom is a second-generation female condom developed by the Female Health Company (FHC). It is based on the polyurethane FC Female Condom but could cost less than half as much. The FC2 Female Condom is made from synthetic latex, which is softer than polyurethane, and is assembled through a dipping process, a less expensive technique than the polyurethane method of welding (137).

The FC2 Female Condom is expected to become available to developing countries in 2005. A phase II clinical trial comparing FC2 with the original FC Female Condom has been completed, and the product is awaiting CE Marking in Europe—a designation indicating that a product meets health and safety standards. The manufacturer also plans to apply for US FDA approval (137).

VA feminine condom. The VA feminine condom, also known as the Reddy female condom and as V-Amour, contains a soft sponge to hold it in place inside the vagina rather than a ring as used in the FC Female Condom. Also, it has a V-shaped external rim. Its manufacturer, Medtech Products Ltd., and Intellx, Inc., introduced it in Germany and Spain on a limited basis in 2002, as the first latex female condom (180).

The VA feminine condom has received CE Marking and will be marketed in Western Europe and in Brazil, India, and South Africa starting in 2005 (155, 180). CONRAD and Family Health International (FHI) are conducting phase III clinical trials on a fifth redesign of the condom to determine effectiveness and acceptability (70, 79, 155). Upon completion of these studies, the manufacturer plans to apply for US FDA approval (180).

PATH Woman’s Condom. Since 1998 PATH has been developing a new female condom. PATH has tested 50 different prototypes for ease of insertion, comfort, stability, design, and cost. The final product consists of a dissolving capsule intended to make insertion easier, a polyurethane condom pouch, and a soft outer ring, allowing for nearly universal fit. Once inserted, sections of urethane foam on the condom pouch allow the condom to cling lightly to the vaginal walls so that it does not move during use (24, 25).

In 2004 PATH completed a study among 60 couples during 180 product uses in Mexico, South Africa, and Thailand. The study found that 98% of women and 99% of their partners were satisfied with the way the condom felt (23). Phase I clinical trials evaluating the safety and acceptability of the PATH Woman’s Condom compared with the original FC Female Condom are currently underway in the US, with support from CONRAD, and are expected to finish by mid-2005. PATH expects US FDA approval in 2007 (23, 24).

Disclaimer: The information provided on this web site is not official U.S. Government information and does not represent the views or positions of the U.S. Agency for International Development or the U.S. Government.