Contraceptive technology has come a long way, but there is still much more work that needs to be done to increase women’s access to safe and effective contraceptive choices.
Since Margaret Sanger overturned anti-contraceptive legislation in 1936, making it legal for doctors to provide diaphragms and spermicides to women, researchers have been working to develop improved contraceptive methods. Oral contraceptives were introduced to the public in the 1960s and paved the way for future innovation. Today, contraceptive hormones are delivered in a variety of ways, including through implants, long-acting injections, patches and vaginal rings.
Yet there is still a gap in contraceptive technology that FHI 360 is working to fill – an effective, safe, easy-to-use, and low-cost vaginal contraceptive.
FHI 360 has developed a new vaginal insert, made of soft, non-woven textile materials that can contain different types of vaginal gels. What makes this insert innovative is that it virtually eliminates leakage of the vaginal gel, a critical issue for both effectiveness and acceptability. The insert is packaged as a single-use, ready-to-use product, pre-moistened with medicated gel. Depending upon the type of gel, the device could be used to prevent pregnancy or HIV or to treat vaginal infections.
Currently, the only over-the-counter vaginal contraceptives that are available are detergent-based spermicides containing nonoxynol-9 or similar agents. Detergent-based spermicides are irritating to vaginal tissues and with frequent use can cause ulcerations that could increase the risk of HIV infection.
The insert could be used with new non-irritating spermicides such as BufferGel® (developed by researchers at Johns Hopkins University) or with a ferrous gluconate formulation (developed by researchers at Cornell University). So far, the Hopkins and Cornell researchers have used other delivery methods, including diaphragms and vaginal rings, for their formulations. The FHI 360 insert could also be used to deliver microbicide gels, considered to be one of the most promising interventions to emerge over the past decade to prevent HIV infection in women.
Results of a pivotal study, presented on September 17 at the Reproductive Health 2011 conference, showed that the combination of BufferGel and the new SILCS® diaphragm—a one-size-fits-all device—was as effective as a diaphragm with nonoxynol-9 gel. This is a double dose of innovation—a new, non-irritating spermicidal gel and a new one-size-fits-all diaphragm—and it’s great news for women.
In 2009, we conducted a Phase I study to assess the acceptability of the FHI 360 insert among women and their male partners in Durban, South Africa, using the device saturated with 10 mL of an FDA-approved vaginal lubricant. We recruited 40 women, who first inserted and removed the device at the clinic and then at home. For home use, we asked women to discuss the product with their male partner and—if their partner agreed—to wear it during intercourse.
Participants found the insert easy to place in the vagina and easy to remove with minimal to non-existent leakage. Most men (34) agreed to have intercourse with the device in place. Participants reported that the insert was comfortable during intercourse. Most women said they would be willing to use the insert for contraception or preventing sexually transmitted infections, including HIV, and most men said they would approve of their female partners using it if it became commercially available.
Once again, we have the potential to advance women’s health in the U.S. and around the world. This is what innovation is all about – improving lives.