A Phase I Randomized Postcoital Testing and Safety Study of the Caya Diaphragm used with 3% Nonoxynol-9 gel, ContraGel, or No Gel

Abstract Objectives The Caya® Diaphragm is a newly approved single-size, non-latex diaphragm. Contragel® is a personal lubricant containing lactic acid approved in Europe and other countries for use with vaginal barrier devices. This study assessed the effectiveness in preventing sperm from penetrating midcycle cervical mucus of Caya with Contragel, Caya with 3% nonoxynol-9 (N-9), and Caya alone. Study Design Phase I multi-center, single-blind, randomized, crossover, non-significant risk study at 2 sites: Eastern Virginia Medical School, Norfolk, VA, and Profamilia, Santo Domingo, Dominican Republic. Healthy, sexually active women 18–45 years old, not at risk for pregnancy due to tubal occlusion were eligible. Each participant was seen in 9 visits, completing a baseline cycle (without product use) followed by 3 test cycles (sequence determined by randomization), each consisting of a cervical mucus check visit and a postcoital test visit. To proceed to test cycles, the baseline postcoital test had to show adequate cervical mucus and>5 progressively motile sperm per high power field (PMS/HPF). Results All women had an average of