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TOL-463 Phase 2 Study for Vaginitis

NCT02866227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2018-03-09

No results posted yet for this study

Summary

This is a Phase II study designed to assess the safety and efficacy of an investigational product, TOL-463, to treat vaginitis.

Conditions

  • Bacterial Vaginosis
  • Vulvovaginal Candidiasis

Interventions

DRUG

TOL-463

TOL-463 vaginal gel

DRUG

TOL-463

TOL-463 vaginal insert

Sponsors & Collaborators

  • Toltec Pharmaceuticals, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-15
Primary Completion
2017-06-10
Completion
2017-06-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02866227 on ClinicalTrials.gov