Optical Imaging and User Perception Study of Vaginal Gel

July 23, 2014 updated by: Duke University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
number and frequency of adverse events
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)
The Miriam Hospital
ImQuest Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David F. Katz, Ph.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00038440
  • U19AI077289 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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