For the new contraceptive efficacy trial, researchers at 10 sites in the United States are enrolling 1,000 women. Participants must be in a sexually active and monogamous relationship and at low risk for infection by sexually transmitted diseases. They must agree not to use other forms of contraception beyond that supplied by the study, and be willing to risk getting pregnant. Study participants will use a diaphragm with either BufferGel or a conventional spermicide.
In this trial, we want to achieve the highest possible level of protection, says Thomas Moench, medical director for ReProtect LLC. Were including a diaphragm because it places a discrete physical barrier over the cervix, significantly enhancing the protective actions of contraceptive microbicides.
Moench, formerly an assistant professor of infectious diseases at the Johns Hopkins Medical Institutions, originally created BufferGel with Cone. Hopkins and ReProtect LLC are developing BufferGel through a cooperative research agreement.
Researchers are also currently planning a larger trial to test BufferGels ability to block transmission of HIV and genital herpes. The trial is scheduled to take place through NIHs HIV Prevention Trials Network next year.