Quantitation of vaginally administered nonoxynol-9 in premenopausal women.
A feasibility study was performed in 11 healthy nonpregnant premenopausal women to determine a method for collection and recovery of vaginally administered nonoxynol-9. We also determined if nonoxynol-9 could be quantitated in vaginal lavage fluid obtained 2 h after instillation of a standard precoitol dose of a foam formulation of nonoxynol-9. Samples were analyzed in batch using a validated normal phase high-performance liquid chromatography (HPLC) method. Two hours after instillation of one dose of Delfen Contraceptive Foam (100 mg), the quantity of nonoxynol-9 collected ranged from 10.8 to 67.8 mg (mean: 35.4 mg). This corresponds to a recovery of 11.70%, of the administered dose. Quantitation of vaginally administered nonoxynol-9 is both practical and feasible. These data represent a critical first step in the evaluation of the safety and effectiveness of nonoxynol-9-containing products in the prevention of sexually transmitted diseases.
Barditch-Crovo
P
P
Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Witter
F
F
Hamzeh
F
F
McPherson
J
J
Stratton
P
P
Alexander
N J
NJ
Trapnell
C B
CB
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006801:Humans; D017137:Nonoxynol / Q000008:administration & dosage / Q000032:analysis*; D017697:Premenopause; D013089:Spermatocidal Agents / Q000008:administration & dosage / Q000032:analysis*; D007507:Therapeutic Irrigation; D014621:Vagina / Q000378:metabolism*
D013089:Spermatocidal Agents; D017137:Nonoxynol