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Developing Rectal USPE Measures for Suppositories (Project DRUM-S)

NCT02744261 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-10

Study results available
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Summary

The purpose of this study is to (a) adapt existing user sensory perception and experience (USPE) items/instruments generated for rectal gel/cream formulations to include USPEs specific to suppository forms for rectal and vaginal use; (b) for both male and female cohorts: to capture the experience of suppository use in the context of receptive anal intercourse (RAI); and (c) for female cohort only: to capture the experience of suppository use in the context of vaginal-penile intercourse (VI), and to compare USPEs of suppository use in the context of RAI to USPEs of suppository use in the context of vaginal-penile intercourse.

Conditions

  • Microbicide Delivery System Perceptibility and Acceptability

Interventions

OTHER

Gel

4 mL

OTHER

Suppository 1

OTHER

Suppository 2

Sponsors & Collaborators

  • ImQuest Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • The Miriam Hospital

    lead OTHER

Principal Investigators

  • Kate Guthrie, PhD · The Miriam Hospital: Centers for Behavioral & Preventive Medicine

  • Robert Buckheit, PhD · ImQuest Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-11
Primary Completion
2017-04-13
Completion
2022-04-01

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 NCT02744261 on ClinicalTrials.gov