Phase II/III Clinical Trial for Contraceptive Efficacy
Two pivotal Phase II/III clinical trials of BufferGel® plus diaphragm as a contraceptive were recently completed in more than 1200 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 results of this trial are reported in: Barnhart et al, “Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: randomized controlled trial” Obstet Gynecol. 2007 Sep;110(3):577-86. .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.
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