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Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463

Vaginal Infection Clinical Trial

Official title:
A Two Part Randomized, Open-Label Phase I Safety and Pharmacokinetic Evaluation of Gel and Ovule Formulations of TOL-463 (Intravaginal Therapy) in 18-45 Year Old Healthy Female Subjects and Women With Vaginitis

Clinical Trial Summary

The purpose of this study is to determine the safety, local tolerability and pharmacokinetic parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females following single dose administration (Part 1), and in nonpregnant women with vaginitis following multi-dose administration (Part 2).

Clinical Trial Description

The purpose of this study is to determine the safety, local tolerability and pharmacokinetic parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females following single dose administration (Part 1), and in nonpregnant women with vaginitis following multi-dose administration (Part 2). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01812889
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date April 2013
Completion date May 2014
View Details
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