Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV

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).

Timeline

Start

2014-12

Primary completion

2016-12

Completion

2017-03

Drugs

Indications