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| AuthorsMarkus J Steiner, PhDLee Warner, PhD, MPHWillard Cates, Jr, MD, MPHKatherine M Stone, MDTheresa Hatzell Hoke, PhD, MPH | Section EditorMimi Zieman, MD | Deputy EditorVanessa A Barss, MD |
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The female condom lines the vagina and shields the introitus, thus providing a physical barrier between male and female genitalia and secretions during sexual intercourse. It is designed to protect against both pregnancy and sexually transmitted infections (STIs), and is available without prescription. There are no contraindications to its use, but it may not be appropriate for women who are not comfortable touching their genitals or who may have other problems with insertion. Female condoms account for less than 1 percent of condoms produced globally [1].
The Reality female condom (FC1) is the only model currently approved by the United States Food and Drug Administration (FDA). It is a soft, loose-fitting polyurethane sheath or pouch with two flexible polyurethane rings. One ring lies within the closed end of the sheath, and serves as an insertion mechanism and internal anchor. The other ring forms the external, open edge of the device; it remains outside the vagina after insertion. There is silicone-based lubricant on the inside of the condom, but additional lubrication can be used. The condom is about 17 cm (6.5 inches) in length (similar to a male condom). The expiration date is five years from the date of manufacture.
Variations to the Reality design described above are available in some areas of the world. Female condoms can also be made of a nitrile polymer, which is a synthetic latex. These condoms perform similarly to the Reality condom [2,3]. The nitrile female condom, known as FC2, is available in 77 countries [4] and received FDA approval in 2009. The FDA's approval states that the FC2 Female Condom is indicated for preventing pregnancy, HIV/AIDS, and other sexually transmitted infections. In addition, the FC2 may make less noise during intercourse than the Reality female condom and is projected to be cheaper when mass produced. The Program for Appropriate Technology in Health (PATH) Woman's Condom (WC) is another new female condom currently in development [5].
The female condom prevents pre-ejaculatory fluid and sperm from entering the vagina. No spermicide is required, but spermicide may be used as a lubricant or for extra protection against pregnancy.
No randomized trials comparing the clinical effectiveness of male and female condoms for prevention of pregnancy and STIs have been performed. However, two randomized crossover trials in the United States and Brazil used the proxy measures of breakage, slippage, and prostate-specific antigen (PSA) as indicators of semen exposure [6,7]. Participants used both condom types, completed condom-specific questionnaires to report problems, and collected precoital and postcoital samples of vaginal fluid for PSA. The PSA detection rates were similar for both the female and male condoms [8]. However, users in both trials reported female condoms were associated with significantly more mechanical problems (eg, slippage, breakage, incorrect penetration) than male condoms.
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