Trials / Completed
CompletedNCT02866227
TOL-463 Phase 2 Study for Vaginitis
A Randomized Single Blind Safety and Efficacy Study of TOL-463 Vaginal Gel or Insert in the Treatment of Vaginitis (BV and/or VVC)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Toltec Pharmaceuticals, LLC · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase II study designed to assess the safety and efficacy of an investigational product, TOL-463, to treat vaginitis.
Detailed description
This is a Phase II randomized single blind safety and efficacy study of TOL-463, administered to female adults to treat vaginitis. Participants will be randomly assigned (1:1) to dose TOL-463 Gel or TOL-463 Insert. Study medication will be administered vaginally, once nightly for seven days. The duration of the study for each participant will be approximately 21-30 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TOL-463 | TOL-463 vaginal gel |
| DRUG | TOL-463 | TOL-463 vaginal insert |
Timeline
- Start date
- 2016-07-15
- Primary completion
- 2017-06-10
- Completion
- 2017-06-10
- First posted
- 2016-08-15
- Last updated
- 2018-03-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02866227. Inclusion in this directory is not an endorsement.