Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary

Summary

The primary objective of the study is to evaluate the local tolerability of the new Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and multiple applications o.d. for 3 days, overall local and general tolerability, safety and comfort of use will also be evaluated.

Timeline

Start

2016-03-04

Primary completion

2016-10-12

Completion

2016-10-12

Publications

• Di Stefano AFD, Radicioni MM, Vaccani A, Caccia G, Focanti F, Salvatori E, Pelacchi F, Picollo R, Rosignoli MT, Olivieri S, Bovi G, Comandini A. Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine. Infect Dis Obstet Gynecol. 2020 May 2;2020:7201840. doi: 10.1155/2020/7201840. eCollection 2020.

Drugs

Indications

No indication recorded.