Women around the world helped us design the Woman’s Condom. Photo: PATH/Glenn Austin.
Woman's Condom expands choices for protection
Condoms offer contraception and protection against HIV in one inexpensive, simple-to-use package. But the most commonly used condoms worldwide are male condoms, which means women who want to use this method depend entirely on their partners’ cooperation.
A female condom equalizes control by a small but significant amount. Unfortunately, the currently available female condoms have not been widely embraced among some groups, due in part to challenges with design features that affect ease of use and comfort.
In 1996, two PATH employees who were working on new reproductive health technologies came up with an exciting idea: what if PATH could refine the female condom, with the cooperation of women and their partners, and come up with a design that would be easy to use and as comfortable or more comfortable than a male condom? The brainstorming sessions that followed brought PATH’s reproductive health and technology experts together on the first incarnation of the Woman’s Condom project, dedicated to producing a female condom that would serve women better through a user-driven design.
As we started to research the problem, we realized that women wanted a female condom that was easier to insert, use, and remove; that was more stable, so they didn’t have to worry that it would be dislodged or move out of place during use; that was more comfortable for both partners (in particular, less noisy); and that interfered less with sensation.
Going to the source
Achieving a truly user-driven product design meant establishing testing sites around the world with populations that varied widely in physical and cultural needs. We gathered input from couples in Khon Kaen, Thailand; Cuernavaca, Mexico; Durban, South Africa; and Seattle, United States throughout the design process. Our researchers observed clinical fittings of prototype condoms and interviewed the couples to find out how they responded to each new design.
The beginning of the final design came after more than four years of hard work spent in assessment, research and development of new materials, and evaluation of hundreds of prototypes. By the end, we had developed and tested more than 50 design generations in more than 300 unique prototypes. The result was a female condom that is easy to insert and remove, is very stable during sex, and feels good for both partners.
What did we change?
The most widely available female condom is shaped like an oversized male condom, with a semiflexible ring at the open end that rests outside the woman’s body and a loose ring inside that helps with insertion and holds the condom in place.
We refined the material until we had something much softer and thinner, which got high marks from female testers. The inner ring was painful for some women, so we replaced it with four small dots of soft, absorbent foam. The foam adheres gently to the interior of the vagina, holding the condom securely in place during use and releasing easily from the vaginal walls on removal. To make insertion easier, we added a rounded cap to the end of the condom, which gathers the condom pouch together until after insertion. Once the condom is inserted, the tip dissolves in less than a minute for most women.
From the lab to the market
Since moving out of product development, the Woman’s Condom has been evaluated among women and couples for acceptability, performance, and safety in clinical trials across five countries. These studies have found that the Woman’s Condom is safe, acceptable, easy to use, and that it performs well when compared to other female condom products.
In 2008, we transferred production of the Woman’s Condom to the Dahua Medical Apparatus Company of Shanghai, China. Dahua has received approvals to market the product in China, Europe, and South Africa.
In addition, the Woman’s Condom achieved prequalification by the World Health Organization (WHO)/United Nations Population Fund (UNFPA) in February 2016. WHO/UNFPA prequalification allows United Nations agencies and other international purchasers to procure the product for public-sector distribution—a critical aspect of expanding global access. Prequalification also serves as an endorsement of quality, efficacy, and safety.
PATH and our partners are working to introduce the Woman’s Condom in developing-country markets and to explore strategies to increase access. Together we are building supply, verifying safety and efficacy, and developing markets for the Woman’s Condom, with initial introduction efforts taking place in China and South Africa. Read about these efforts here.
These steps are bringing us closer to our ultimate vision: that the Woman’s Condom will be a broadly available and affordable option for those seeking protection from pregnancy and sexually transmitted infections, including HIV.