A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of XXXX Vaginal Gel 1.3% in the Treatment of @entity6981 .

@entity1 @entity868 @entity2953 @entity281 @entity6981
BACKGROUND: @entity6981 ( @entity6981 ), a prevalent @entity281 in @entity1 of reproductive age, is associated with increased risk of upper genital tract and @entity2953 , and complications in pregnancy. Currently approved treatments include @entity868 , which requires once or twice daily intravaginal administration for 5 days or twice daily oral administration for 7 days. This phase 3 study determined the safety and efficacy of single-dose @entity868 vaginal gel (MVG) 1.3%. METHODS: In this double-blind, vehicle-controlled study, 651 @entity1 with clinical diagnosis of @entity6981 were randomized 1:1 to receive MVG 1.3% or vehicle vaginal gel. Primary efficacy measure was clinical cure (normal discharge, negative "whiff test," and <20% clue cells) at day 21. Secondary measures included therapeutic cure (both clinical and bacteriological; day 21) and bacteriologic cure (Nugent score <4), clinical cure, and time to resolution of symptoms (day 7). RESULTS: A total of 487 @entity1 were included in the primary analysis. Clinical and therapeutic cure rates (day 21) were higher in @entity1 treated with MVG 1.3% compared with vehicle gel (37.2% vs. 26.6% [P = 0.010] and 16.8% vs. 7.2% [P = 0.001], respectively). Clinical and bacteriologic cure rates (day 7) were also higher in the MVG 1.3% group (46.0% vs. 20.0% [P < 0.001] and 32.7% vs. 6.3% [P < 0.001], respectively). The median time to resolution of symptoms was shorter in the MVG 1.3% (day 6) than vehicle group (not reached). No serious adverse events were reported, and incidence was similar across treatment groups. CONCLUSIONS: Single-dose MVG 1.3% was safe and superior to vehicle gel in producing cure among @entity1 with @entity6981 .
