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Optical Imaging and User Perception Study of Vaginal Gel

This study has been completed.
Sponsor:
Collaborators:
ImQuest Pharmaceuticals, Inc.
The Miriam Hospital
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01716000
First received: October 24, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Characterize Gel Distribution in the Vagina
Study Women's Sensory Perceptions and Preferences of Gel
Other: vaginal gel imaging
Behavioral: computer aided self interview

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Optical Imaging and User Perception Study of Vaginal Gel

Further study details as provided by Duke University:

Primary Outcome Measures:
  • number and frequency of adverse events [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • extent of vaginal gel coating [ Time Frame: at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1) ] [ Designated as safety issue: No ]
    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

  • uniformity of vaginal gel coating [ Time Frame: at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1) ] [ Designated as safety issue: No ]
    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

  • subject perception and preference of vaginal gel [ Time Frame: at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1) ] [ Designated as safety issue: No ]
    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.


Enrollment: 56
Study Start Date: January 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716000

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
ImQuest Pharmaceuticals, Inc.
The Miriam Hospital
Investigators
Principal Investigator: David F. Katz, Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01716000     History of Changes
Other Study ID Numbers: Pro00038440, U19AI077289
Study First Received: October 24, 2012
Last Updated: July 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
vaginal gel
vaginal coating
sensory perceptions

ClinicalTrials.gov processed this record on November 27, 2014