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A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101

NCT03537092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-01-13

Study results available
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Summary

This is a phase I randomized trial assessing the safety of a single vaginal placebo film application. In order to develop a vaginal film which can provide extended release of an Antiretroviral (ARV), the film polymers and formulation have been altered from the cellulose and polyvinyl alcohol films used to deliver dapivirine and tenofovir in previous trials. Therefore, the proposed study will evaluate the safety and persistence of these film polymers when applied vaginally.

Conditions

  • Safety of Vaginal Film Use

Interventions

DEVICE

Vaginal Film

2" x 2" vaginal film with no active drug

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Katherine Bunge

    lead OTHER

Principal Investigators

  • Katherine Bunge, MD · University of Pittsburgh

  • Sharon L Hillier, PhD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2018-12-04
Completion
2018-12-04
FDA Device
Yes

Countries

  • United States

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 NCT03537092 on ClinicalTrials.gov