CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Tenofovirdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01283555
NCT01283555N/ACompleted
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Comparative Safety Study of Pre-Filled Plastic and User-Filled Paper Vaginal Applicators With Candidate Microbicide, Tenofovir

PATH·interventional·Posted Jan 26, 2011·Updated Jul 16, 2012

In Brief

A clinical study evaluating Tenofovir for Microbicide Applicator. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The primary objective of this study is to compare the effect of two vaginal applicators, delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily use. The secondary objectives are to: 1. Evaluate and compare the dosing accuracy and precision of the user-filled applicator and pre-filled applicator with the candidate microbicide, Tenofovir. 2. Compare the acceptability of the user-filled applicator with the pre-filled applicator.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMicrobicide Applicator
CountriesDominican Republic
CollaboratorsCONRAD, Profamilia, Santo Domingo, DR

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2011
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.4 years ago

Interventions

Tenofovirdrug

Delivered using prefilled and user-filled applicator