Trial 1 enrolled 144 non-pregnant female patients aged 19 to 54 years and Trial 2 enrolled 189 non-pregnant females aged 18 to 54 years. Black or African American subjects in both trials were 54%. Efficacy was assessed by clinical outcome eva luated 21 to 30 days following a single dose of SOLOSEC. A clinical responder was defined as "normal" vaginal discharge, negative "whiff" test, and clue cells <20%. Additional endpoints included Nugent score cure (Nugent score of 0-3) and therapeutic outcome. A therapeutic responder was defined as a clinical responder with a Nugent score cure. In Trial 2, the endpoints were also assessed at Day 7-14.

 

In both trials, a statistically significantly greater percentage of patients experienced clinical response, Nugent score cure, and therapeutic response at 21 to 30 days following a single dose of SOLOSEC compared to placebo. Statistically significant results for the endpoints were also achieved at Day 7-14 in Trial 2.

 

The percentage of patients with clinical response was also consistently higher in both trials in the SOLOSEC arm compared to placebo among all subsets of patients: number of prior episodes of bacterial vaginosis (≤ 3 episodes and ≥ 4 episodes) in past 12 months, baseline Nugent score (score 4-6 and score 7-10), and race (Black/African American and White). Tables 3 and 4 describe the efficacy of SOLOSEC in the treatment of bacterial vaginosis.

 

Table 3. Efficacy of SOLOSEC for Treatment of Bacterial Vaginosis in Two Randomized, Double-Blind, Placebo-Controlled Trials in Modified-Intent-to-Treat Population at 21-30 Days 

Trial 1

 

Trial 2

 

SOLOSEC

(N=62)* 

n (%)

 

Placebo

(N=62)* 

n (%)

 

SOLOSEC

(N=107)* 

n (%)

 

Placebo

(N=57)* 

n (%)

* N=number of patients in treatment group (modified intent-to-treat population defined as all patients randomized who had a baseline Nugent score ≥4 and were negative for other sexually transmitted infections at baseline). † Patients missing one or more of the clinical assessments were considered as non-responders/not cured. ‡ Difference in response (SOLOSEC – placebo) and 95% confidence interval § Patients with missing Nugent scores were considered Nugent score failures.  

 

Clinical Responder† 42 (67.7) 11 (17.7) 57 (53.3) 11 (19.3) 

 50.0 (33.4, 66.7)‡ 

p<0.001 34.0 (18.7, 49.3)‡ 

p<0.001 

Nugent Score Cure§ 25 (40.3) 4 (6.5) 47 (43.9) 3 (5.3) 

 33.8 (18.5, 49.1)‡ 

p<0.001 38.6 (26.2, 51.0)‡ 

p<0.001 

Therapeutic Responder 25 (40.3) 4 (6.5) 37 (34.6) 2 (3.5) 

 33.8 (18.5, 49.1)‡ 

p<0.001 31.1 (19.6, 42.6)‡ 

p<0.001