NCT02713893

Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream

A Phase I Study of a Novel Intravaginal Antimycotic Cream (Econazole Nitrate 1% Plus Benzydamine HCl 0.12%) Administered Once Daily for 15 Days to Healthy Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate local tolerability of the new Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and repeated applications once a day for 15 days, safety of the investigational products and comfort of use will also be evaluated as secondary objectives.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream
DRUG	Placebo plus Econazole nitrate 1% intravaginal cream
DRUG	Placebo plus Benzydamine HCl 0.12% intravaginal cream
DRUG	Placebo intravaginal cream

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-15
• First posted: 2016-03-21
• Last updated: 2018-01-17

Locations

1 site across 1 country: Switzerland