Phase II/III Clinical Trial for Contraceptive Efficacy

ReProtect, Inc.
September 2000

Two pivotal Phase II/III clinical trials of BufferGel® plus diaphragm as a contraceptive were recently completed in more than1,200 women, funded by the National Institutes of Health (NIH, NICHD Contraceptive Branch).

• The first and larger trial was a randomized comparative study designed to test the non-inferiority of BufferGel to a marketed comparison spermicide, Gynol II, both products used with a diaphragm. The trial found BufferGel to be non-inferior to Gynol II; the point estimates of pregnancy rates were lower for BufferGel than for Gynol II.
• The second, an open label trial, confirmed BufferGel’s effectiveness.

Thus, BufferGel with a diaphragm is a safe and effective contraceptive. The data were recently presented at an international scientific meeting.These successful trials represent a major milestone for ReProtect, and constitute the pivotal efficacy trials needed in preparation for New Drug Application (NDA) to the US FDA.