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Comparative Safety Study of Two Vaginal Applicators With Tenofovir

NCT01283555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-07-16

Study results available
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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.

Conditions

  • Microbicide Applicator

Interventions

DRUG

Tenofovir

Delivered using prefilled and user-filled applicator

Sponsors & Collaborators

  • CONRAD

    collaborator OTHER

  • Profamilia, Santo Domingo, DR

    collaborator UNKNOWN

  • PATH

    lead OTHER

Principal Investigators

  • Vivian Brache · Profamilia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Dominican Republic

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 NCT01283555 on ClinicalTrials.gov