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Female condoms hit the spotlight Will U.S. women see more options?
Candidates such as Woman's Condom, Origami may boost use
Since its introduction in 2009, use of the non-latex FC2 Female Condom (Women's Health Co., Chicago) has grown. In fact, the number of FC2s distributed in the United States tripled in the past year.1
The cost of a pack of three FC2 Female Condoms ranges between $5.99 and $7.99.2
The FC2 is enjoying success in Washington, DC, where all 55 CVS drug stores carry it, and public heath officials in San Francisco kicked off a new FC2 awareness campaign on Feb. 14, 2011. Houston public health officials followed suit in March 2011 by initiating their own awareness campaign about the barrier protection method.
However, as family planners know, options in choice might encourage more women in selecting a prevention method. Two new female condoms are on the horizon: the Woman's Condom developed by PATH in Seattle, and the Origami, under research by Strata Various Product Design in Culver City, CA.
The Woman's Condom is a thin polyurethane pouch with several features that distinguish it from other designs. The pouch is packaged into a thin capsule (similar to an OB tampon) that helps with handling and insertion. When the capsule is inserted in the vagina, it quickly dissolves, allowing the vaginal pouch to unfold. Four small foam shapes attached to the vaginal side of the pouch lightly adhere to the vaginal wall and help keep the pouch stable during sex.3
The sheath is made of 0.03 mm polyurethane film and allows good sensation and comfort. The soft, low profile outer ring fits snugly against the pubic region4.
Condom performance is evaluated through performance and failure mode studies. These studies of the Woman's Condom in the United States, South Africa, and China indicate the Woman's Condom performs well during use, with few clinical failures. Two additional studies ongoing in the United States will provide additional data that will be submitted to the Food and Drug Administration (FDA). CONRAD, an Arlington, VA, reproductive health research organization, is conducting a performance and failure mode study, also including prostate specific antigen (PSA) as a biomarker of semen exposure. Results from this study are expected by the end of 2011. The Eunice Kennedy Shriver National Institute of Child Health and Human Development is conducting a pivotal contraceptive effectiveness study of the Woman's Condom during 2011 and 2012. Data will be submitted to FDA as part of a premarket approval application, according to Patricia Coffey, MPH, PhD, Woman's Condom team leader and senior program officer at PATH.
Clinical studies in several countries indicate good acceptability with the Woman's Condom.3, 5-6 PATH recently received a four-year grant from the Netherlands Ministry of Foreign Affairs that will support additional production scale up, regulatory applications, and production introduction in China and sub-Saharan Africa. This new product development partnership, known as Protection Options for Women Product Development Partnership, seeks to advance the Woman's Condom and expand affordable protection options for women. Other partners include the Shanghai (China) Dahua Medical Apparatus Company, CONRAD, and the Eunice Kennedy Shriver National Institute of Child Health and Development.
Progress is being made in bringing the Woman's Condom to diverse markets. In December 2010, the condom was granted CE Mark approval. The approval certifies the condom meets product quality standards for marketing in European Union countries. In addition, Dahua has submitted an application to the China Food and Drug Administration for clearance to market the Woman's Condom in China. Response is anticipated in early 2011.
Origami in early studies
Further out in the research pipeline is the Origami female condom. The condom is made of a uniquely formulated silicone, says Ray Chavez, project coordinator at Strata Various Product Design in Culver City, CA. The material has been independently lab tested to have zero viral permeability using one of the smallest viruses known, the Phi-X174 bacteriophage, states Chavez. The silicone has high elongation and tensile strength properties to guard against breakage.
The Origami is designed with a no-fumble insertion method, part of a patent-pending feature based on a user-friendly telescoping design. The condom is inserted as a small dome-shaped cap that lodges in the vagina. The condom then deploys to its full length at the start of intercourse.
According to Chavez, the Origami is designed to optimize pleasure for both partners and simultaneously increase safety. The material is intended to simulate the properties of human tissue to resemble "sex-without-a-condom." "This is intended to make the [condom] more attractive to both men and women and increase correct and consistent female condom usage for those at risk," states Chavez.
Future studies will address the condom's potential as a reusable device for married couples. Preliminary experiments indicate the material can support multiple rigorous washings, cleaning agents such as bleach, and even microwave heating, says Chavez. The product also is designed to tolerate temperatures up to 425°F, which could help to extend its shelf life, he notes.
Research and development efforts to refine Origami prototypes were scheduled to be completed by April 2011. Preliminary prototypes were scheduled for human testing beginning in May 2011, with testing completed in February 2012. Phase I research, funded by the National Institutes of Health, is being conducted in collaboration with the Women's Global Health Imperative at the San Francisco office of RTI International, says Chavez.
The protocol includes two human volunteer studies. First is a user preference study, which will evaluate the design preferences and non-coital aspects of acceptability to identify which prototype is the most comfortable and acceptable. The second study is a couples' acceptability and performance study, which will compare the performance and acceptability of the preferred condom prototype during sex to that of commercially available condoms. A Phase II study will follow. If successful, commercialization plans are anticipated mid-year in 2014, says Chavez.