Safety and efficacy of bedtime versus daytime administration of the miconazole nitrate 1200 mg vaginal ovule insert to treat vulvovaginal candidiasis.

OBJECTIVE: Most vaginal products are self-administered at bedtime. Safety, efficacy, and ' therapeutic cure with bedtime versus daytime treatment of vulvovaginal candidiasis (VVC) were assessed to potentially improve compliance and convenience with vaginal antifungal treatment.
METHODS: A non-inferiority study evaluated 573 women with symptoms of WC, randomized to daytime or bedtime self-administration of single dose of miconazole nitrate 1200 mg vaginal ovule (Monistat-1).
RESULTS: Subjects (n = 149) were evaluated for efficacy in the Daytime group and 163 in the Bedtime group. In the Daytime group, 86 (57.7%) participants achieved therapeutic cure, with 105 (70.5%) and 111 (74.5%) exhibiting mycologic and clinical cures, respectively. In the Bedtime group, 83 (50.9%) subjects achieved therapeutic cure, with 104 (63.8%) and 120 (73.6%) exhibiting mycologic and clinical cures, respectively (NS). There was no significant difference in the incidence of side effects between the two groups. Median estimated time to initial relief of itching, burning and irritation was similar for both. Miconazole nitrate 2% cream was also applied twice daily to the vulvar area for external symptoms for up to 7 days. Test-of-cure was assessed 21 days-30 days following administration of intra-vaginal drug. Time to vulvovaginal symptomatic relief and the effect of activity following daytime administration on therapeutic cure were also assessed.
CONCLUSION: The efficacy against a broad spectrum of pathogens and acceptability of daytime and bedtime administration of miconazole nitrate 1200 mg vaginal ovule were similar. These findings offer women a convenient option for treatment for WC, whether self-managed or managed by their healthcare provider.

RCT Entities:   Population Interventions Outcomes