NCT01812889

Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed 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).

Conditions

• Vaginal Infection

Interventions

Type	Name	Description
DRUG	TOL-463 Vaginal ovule	TOL-463 Vaginal Ovule
DRUG	TOL-463 Vaginal gel	TOL-463 Vaginal Gel

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-01-01
• Completion: 2014-05-01
• First posted: 2013-03-18
• Last updated: 2014-05-16

Locations

1 site across 1 country: United States