Trial intelligence / Profile preview

TOL-463 Vaginal Gel or Insert for Vaginitis

NCT02866227Phase 2

Key facts

Status: Completed
Start: Jul 2016
Primary completion: Jun 2017
Countries: 1
Sponsor: Toltec Pharmaceuticals
Modality: Small Molecules

Drugs: TOL-463
Conditions: bacterial vaginosis (BV)vulvovaginal candidiasis (VVC)

Overview

Phase 2, randomised, single-blind trial of TOL-463 in bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) (2 arms), sponsored by Toltec Pharmaceuticals. Primary endpoints: Proportion of participants with clinical cure at Visit 2 among participants with VVC at baseline overall, Proportion of participants with clinical cure at Visit 2 among participants with BV at baseline overall and 2 more. Started Jul 2016; status: completed.

Design

2 arms

Study design: RandomizedSingle-blind

TOL-463 Gel
TOL-463 vaginal gel administered nightly for 7 days
TOL-463 Insert
TOL-463 vaginal insert administered nightly for 7 days

Who it enrols

Adult females 18-50 with a diagnosis of bacterial vaginosis (Amsel criteria) and/or vulvovaginal candidiasis (positive KOH and symptoms). Must agree to abstain from sexual intercourse during treatment and use effective birth control.

Endpoints

Primary

Proportion of participants with clinical cure at Visit 2 among participants with VVC at baseline overallDay 9-12
Proportion of participants with clinical cure at Visit 2 among participants with BV at baseline overallDay 9-12
Proportion of participants with clinical cure at Visit 2 among participants with BV at baseline by armDay 9-12
Proportion of participants with clinical cure at Visit 2 among participants with VVC at baseline by armDay 9-12

Secondary

Median time to symptom reliefDay 1-7
Occurrence of adverse events considered product-relatedDay 1-30
Proportion of participants with microbiologic cure (Nugent score 0-3)Day 21-30
Proportion of participants with mycological cureDay 21-30
Proportion of participants with therapeutic cureDay 21-30

Beyond the preview

Go deeper on NCT02866227.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT02866227.