A new formulation of miconazole nitrate in the treatment of vulvovaginal candidiasis


Upmalis, D.H.; Lamia, C.A.; Harley, J.A.; Cone, F.L.

Advances in Therapy 15(1): 14-22

1998


Two hundred eighty (280) patients with symptomatic vulvovaginal candidiasis were randomly assigned to treatment with either miconazole nitrate 4% vaginal cream for 3 days, followed by placebo for 4 days, or Monistat 7 (miconazole nitrate 2%) vaginal cream for 7 days in this days in this double-blind, parallel-group, outpatient study. Sixteen US centers participated. Patients were seen on admission and then at 8 to 10 days and 30 to 35 days after completion of treatment. Clinical, microbiologic, and therapeutic efficacy was assessed. This study compared the safety and efficacy of a new cream formulation of 5 g of miconazole nitrate 4% administered once daily for 3 days with that of 5 g of miconazole nitrate 2% vaginal cream, the currently marketed product, administered for 7 days. Although not significantly clinically different, cure rates were slightly higher with the 3-day treatment. Relapse rates were low in both treatment groups and symptom relief was also comparable. The most frequent adverse experiences were genital (itching, burning, irritation, and discharge), as well as headache and respiratory congestion; reports of adverse experiences were similar in the two treatment groups. Miconazole nitrate 4% vaginal cream administered for 3 days is a promising new candidate for over-the-counter treatment of vulvovaginal candidiasis.