Objective: In a phase 3 clinical trial we compared the efficacy and side ef
fects of a new local antiseptic solution (Octeniphen(R)) with that of povid
one-iodine vaginal suppositories for the treatment of bacterial vaginal inf
ections (bacterial colpitis, bacterial fluor vaginalis, bacterial vaginosis
).
Methods: A total of 308 patients were enrolled and randomly assigned to rec
eive 7 days of local therapy with one of the two agents. Patients were reex
amined clinically and microscopically at 7 days.
Results: Improvement of symptoms was more frequent in patients using Octeni
phen(R) than in those using povidine-iodine (75% vs. 65%, respectively; t =
1.89). Restitution of lactobacilli was significantly more common (46% vs.
29%, t = 2.76) and patient compliance better with Octeniphen(R). No changes
in cytomorphology or proliferation of the vaginal epithelium was seen in e
ither group. Both agents were well tolerated.
Conclusion: Octeniphen(R) appears to be effective and well tolerated for th
e treatment of bacterial vaginal infections.