A phase I comparative study of three contraceptive vaginal films containing nonoxynol-9. Postcoital testing and colposcopy.

ABSTRACT

PIP: In this Phase I study, 10 US women underwent sequential testing of 3 contraceptive vaginal films containing nonoxynol-9 (N-9): a new Allendale-N-9 film containing either 100 or 130 mg of the spermicide or the commercially available VCF product containing 70 mg of N-9. After a midcycle cervical mucus specimen was collected, women had intercourse using either no film (2 baseline cycles) or a test film and returned 2-3 hours later for further testing. The average number of progressively motile sperm seen per high power field were as follows: average of the 2 baseline cycles, 19.3; test cycle with Allendale-N-9 film containing 100 mg N-9, 0.6; test cycle with Allendale-N-9 film containing 130 mg N-9, 0.9; and test cycle with VCF, 0.5. In 1 baseline and 8 test cycles, colposcopy revealed superficial de-epithelialization. De-epithelialization occurred least often when the 100 mg Allendale film was used. None of the women who experienced de-epithelialization reported symptomatic irritation. These findings indicate that the new contraceptive product containing either 100 or 130 mg of N-9 is safe and comparable to the VCF product in terms of preventing sperm from entering midcycle cervical mucus.