Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
In this open label study, 50 eligible women will be assigned to receive the investigational
product (IZN-6NVS) - 2.5 g of cream/day for 14 days, followed by 3 applications per week for
the next 4 weeks. Clinical assessment of the severity of vaginitis will be performed at
baseline and after 2 and 6 weeks of treatment.
The study will evaluate safety, tolerability and efficacy of IZN-6NVS vaginal cream, in the
treatment of atrophic vaginitis (AV) and desquamative inflammatory vaginitis (DIV).