A phase I randomized safety study of a single-size silicone rubber diaphragm used with or without a lactic-acid-containing diaphragm gel

To evaluate a lactic-acid-containing diaphragm gel (Contragel®) approved outside the United States for use with a silicone rubber diaphragm (Caya®). The study gel is being evaluated as a safer alternative to nonoxynol-9 (N-9) gel, which has been associated with risk of increasing susceptibility to human immunodeficiency virus (HIV).This was a Phase I randomized, parallel study evaluating the safety of the novel diaphragm gel versus...