Quantitation of vaginally administered nonoxynol-9 in premenopausal women.

ABSTRACT

PIP: In clinical trials, nonoxynol-9 has been shown to protect against the transmission of sexually transmitted pathogens. Conversely, there are concerns that frequent use may lead to vaginal irritation and thus increase the risk of transmission of sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV). Nonoxynol-9 is available as a foam, cream, gel, film, and suppository. These routes of administration differ from each other in their total unit dose, ability to irritate genital tissues, rates of dissolution, and ability to coat the vagina. To determine a method for collection and recovery of vaginally administered nonoxynol-9, and thereby facilitate research on the role of nonoxynol-9 in the prevention of HIV, a feasibility study was performed in 11 healthy, premenopausal US women. Also investigated was whether nonoxynol-9 could be quantitated in vaginal lavage fluid obtained 2 hours after instillation of 100 mg of nonoxynol-9 foam (Delfen). The quantity of nonoxynol-9 collected at this time ranged from 10.8-67.8 mg (mean, 35.4 mg), corresponding to a recovery rate of 11-70% of the original dose. Although further studies are needed to optimize methods for nonoxynol-9 recovery from the vagina, this study suggests it is feasible to quantitate nonoxynol-9 after single-dose vaginal administration.