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Optical Imaging and User Perception Study of Vaginal Gel

NCT01716000 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-07-24

No results posted yet for this study

Summary

This study will compare two investigational techniques for measuring how vaginal gels spread and coat the vagina. This study will also explore the experiences and opinions of women using this vaginal gel. We want to understand how the characteristics of a gel, such as a gel's thickness or consistency, affect how the gel spreads and feels in the body. We hope to use the information we learn from this study to develop future vaginal gels that could be combined with medications and used to slow down or stop the spread of sexually transmitted infections.

Conditions

  • Characterize Gel Distribution in the Vagina
  • Study Women's Sensory Perceptions and Preferences of Gel

Interventions

OTHER

vaginal gel imaging

Imaging of vaginal gel distribution using two investigational techniques (low coherence interferometry and fluorimetry).

BEHAVIORAL

computer aided self interview

Questionnaire to gather the perceptions and preferences of the subject with respect to the vaginal gel.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • ImQuest Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • The Miriam Hospital

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • David F. Katz, Ph.D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01716000 on ClinicalTrials.gov