NCT01716000

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

10 months

First QC Date

October 24, 2012

Last Update Submit

July 23, 2014

Conditions

Characterize Gel Distribution in the VaginaStudy Women's Sensory Perceptions and Preferences of Gel

Keywords

vaginal gelvaginal coatingsensory perceptions

Outcome Measures

Primary Outcomes (1)

  • number and frequency of adverse events

    up to 6 months

Secondary Outcomes (3)

  • extent of vaginal gel coating

    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

    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

    at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1)

Study Arms (2)

2 mL vaginal gel

EXPERIMENTAL

2 mL gel inserted vaginally for completion of vaginal gel imaging and computer aided self interview.

Other: vaginal gel imagingBehavioral: computer aided self interview

4 mL vaginal gel

EXPERIMENTAL

4 mL gel inserted vaginally for completion of vaginal gel imaging and computer aided self interview.

Other: vaginal gel imagingBehavioral: computer aided self interview

Interventions

vaginal gel imagingOTHER

Imaging of vaginal gel distribution using two investigational techniques (low coherence interferometry and fluorimetry).

2 mL vaginal gel4 mL vaginal gel
computer aided self interviewBEHAVIORAL

Questionnaire to gather the perceptions and preferences of the subject with respect to the vaginal gel.

2 mL vaginal gel4 mL vaginal gel

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Study Officials

  • David F. Katz, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2012

First Posted

October 29, 2012

Study Start

January 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

US(1)