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NCT01812889 · ClinicalTrials.gov registry record · Phase 1

Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT01812889 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 26 participants.

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The verdict

NCT01812889, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study 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).

Interventions

  • DRUG TOL-463 Vaginal ovule
  • DRUG TOL-463 Vaginal gel

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2013-04
Est. Completion 2014-05
Phase Phase 1

What the Registry Record Tells You About NCT01812889

The ClinicalTrials.gov registry entry for NCT01812889 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which TOL-463 Vaginal ovule is the first listed.

NCT01812889 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01812889 about?

NCT01812889 is a clinical study titled "Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463". 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...

What is the current status of trial NCT01812889?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2013-04. Estimated completion is 2014-05.

What interventions are being tested in trial NCT01812889?

The interventions under investigation include: TOL-463 Vaginal ovule (DRUG), TOL-463 Vaginal gel (DRUG).

Who is sponsoring clinical trial NCT01812889?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.