U.S. trials on contraceptive gel begin via the Internet.
OmniComm Systems, Inc. (OMCM), Miami, Florida, announced it is partnering with Optima WorldWide, Ltd., to launch US testing of a vaginal gel for the potential prevention of pregnancy and the most common sexually transmitted diseases (STDs). Surete Gel, which is already being sold in China as a vaginal disinfectant and contraceptive, is being tested as a potential preventive agent for most STDs, including HIV. The concept of an antimicrobial product that prevents infectious sexual diseases has long been awaited by experts at the WHO and the US National Institutes of Health as an important weapon in preventing the global STD and HIV epidemics. OmniComm's Internet electronic data capture system, TrialMaster, and its web portal for trial investigators and participants, WebIPA.com, will manage long-term testing of Surete Gel worldwide. Stephen Drake, Optima, is hailing the partnership with OmniComm as a big step forward. "We are very pleased with this alliance as we complete trials on Surete Gel. This brings us closer to bringing a microbicide gel to the important US market while our vaginal disinfectant and contraceptive is already being introduced abroad". Optima is awaiting approval to sell Surete Gel in India and Thailand, as well as in several African and European nations. OmniComm is expanding its trial investigator base for Surete clinic trials in the US by enrolling experienced US investigators in the field of gynecology. A number of trial participants will be needed to take part in extensive testing before the product can be considered for approval in the US as more than a contraceptive. Surete complies with the US Food and Drug Administration monograph as a contraceptive. Anyone interested in taking part in those clinical trials--investigators or participants--must register thru OmniComm's web portal, WebIPA.com.
D000569:Americas; D002986:Clinical Trials as Topic; D003267:Contraception; D019049:Developed Countries; D005193:Family Planning Services; D009656:North America; D016730:Program Development; D012106:Research; D013089:Spermatocidal Agents; D014481:United States
D013089:Spermatocidal Agents
Americas; Clinical Research; Clinical Trials; Contraception; Contraception Research; Contraceptive Effectiveness; Contraceptive Methods; Developed Countries; Family Planning; North America; Northern America; Progress Report; Research Methodology; United States; Vaginal Spermicides