Optical Imaging and User Perception Study of Vaginal Gel

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.

Study Overview

• Status: Completed
• Conditions: Characterize Gel Distribution in the Vagina; Study Women's Sensory Perceptions and Preferences of Gel
• Intervention / Treatment: Other: vaginal gel imaging; Behavioral: computer aided self interview

Detailed Description

The pharmacokinetics of a microbicide gel, i.e. the time- and space-dependent distribution of its active microbicidal ingredient(s) (APIs) throughout the body, derives from the time- and space-dependent distribution of the gel itself within the vaginal canal. That distribution may also serve as a physical barrier that retards migration of semen-borne HIV virions to epithelial surfaces. Within the vagina, the gel creates local physical forces ("stresses") against the epithelial surfaces; and its distribution along the canal might be so extensive that gel leaks out from the introitus. A woman may have sensations of those stresses and also feel gel leakage. Thus, intravaginal microbicide gel distribution is central to both its biological functioning (to deliver APIs and also to slow HIV transport) and the behavioral perception of it by users (i.e. how it "feels" and whether that experience is pleasurable or not). The latter, in turn, can govern acceptability of the gel and adherence to designated gel use in clinical trials. This study will characterize and correlate gel distribution and women's sensory perceptions and preferences of that distribution, for two relevant volumes (2 mL and 4 mL) of a current microbicide placebo gel. An optical vaginal imaging device will measure gel distribution in the vagina. A computer-assisted self-interview (CASI) survey will capture women's perceptions and preferences.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• have had vaginal penetrative intercourse within the last 12 months
• have a regular menstrual cycle (between 24-35 days) and be able to record the day of onset of menses in a menstrual diary
• able to ambulate for 20 consecutive minutes after vaginal self-insertion of gel using an applicator
• willing to use a condom when engaging in sexual intercourse within 4 days before a study visit
• willing to avoid using any mechanical sex toy within 1 day before a study visit
• willing to use one of the following contraception methods if engaging in sexual intercourse during the length of participation in the study (hormonal contraceptive, tubal ligation, non-surgical procedure such as permanent transcervical sterilization, Fallopian tubes removed, partner vasectomy)
• able to provide informed consent

Exclusion Criteria:

• pregnant, potentially pregnant, nursing, or trying to conceive
• allergic to latex, fluorescein, hydroxyethylcellulose, ascorbic acid, sodium citrate, citric acid
• using an intrauterine device (IUD)
• using depo-provera
• douching during the course of participation in the study
• had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
• have a gynecological infection or other condition requiring treatment, such as candidiasis, chlamydia trachomatis, trichomoniasis, HIV, herpes simplex virus (HSV), neisseria gonorrhea, symptomatic bacterial vaginosis, or syphilis
• currently enrolled in any other research studies involving the application of vaginal formulations
• employed or supervised by the study investigators
• have any other condition that, in the opinion of the study physician, would contraindicate participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 mL vaginal gel; 2 mL gel inserted vaginally for completion of vaginal gel imaging and computer aided self interview.	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.
Experimental: 4 mL vaginal gel; 4 mL gel inserted vaginally for completion of vaginal gel imaging and computer aided self interview.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number and frequency of adverse events	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extent of vaginal gel coating	extent of vaginal gel coating is measured by: algebraic and harmonic mean gel thickness, total vaginal surface area with detectable gel coating, fraction of total vaginal surface area containing detectable gel coating, linear extent of gel coating along the vaginal canal, ratio of linear extent of coating to the length of the vaginal canal	at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1)
uniformity of vaginal gel coating	uniformity of vaginal gel coating is measured by: coefficient of variation of local coating thickness and the number, location, and sizes of individual bare spots of uncoated vaginal surface within the overall gel coating envelope	at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1)
subject perception and preference of vaginal gel	responses to the computer aided self interview questions, grouped into the following scales: Leaks with Application, Ease of Application, Portability, Intravaginal Feel, Perception of Leakage with Ambulation, Leaking with Ambulation, Leakage Across Time, Sticky with Ambulation, Perception of Natural Wetness, and Lubrication Moisture on Ambulation.	at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); The Miriam Hospital; ImQuest Pharmaceuticals, Inc.
• Investigators: Principal Investigator: David F. Katz, Ph.D., Duke University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: vaginal gel; vaginal coating; sensory perceptions
• Other Study ID Numbers: Pro00038440; U19AI077289 (U.S. NIH Grant/Contract)