A new vaginal antimicrobial contraceptive formulation: phase I clinical pilot studies

Pilot clinical trials were performed with a new vaginal suppository called "Long Acting, Sustained Release of Spermicide" ("LASRS"). No visual or colp oscopic lesions or patient complaints occurred as a result of using LASRS w ith increasing doses of nonoxynol-9 (up to 20%) for 5 days or of applying t he highest dose of nonoxynol-9 (20%; total 400 mg) for 8 h. Colposcopic or visual lesions were also not induced when LASRS with 20% nonoxynol-9 was us ed for 7 consecutive days by the study participants except for those who de veloped symptomatic monilia vaginitis. Symptoms were reported although thes e were mostly minor. A long-lasting, bioadhesive, translucent layer (film) of formulation formed over the vaginal and cervical surfaces. Postcoital sp ermicidal studies showed LASRS to be highly effective for prolonged periods of time. Although intercourse was delayed for 5 to 8.5 h after insertion o f the formulation, an average of only 0.2 motile sperm/HPF could be found i n cervical mucus. These studies suggest LASRS to possess advantages over pr esently marketed formulations by having long-term efficacy and by forming a bioadhesive, presumably protective layer over the genital tract epithelium . The results also suggest the formulation to decrease the vaginal irritati on caused by nonoxynol-9 as noted by colposcopy. These pilot data support a more extensive study with the LASRS suppository. (C) 2000 Elsevier Science Inc. All rights reserved.