Optical Imaging and User Perception Study of Vaginal Gel

Completed · Not applicable

Conditions studied: Characterize Gel Distribution in the Vagina, Study Women's Sensory Perceptions and Preferences of Gel

In brief

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.

Key facts

Study ID

NCT01716000

Run by

Duke University

People needed

56

Starts

2013-01-01

Expected to finish

2013-11-01

Last updated by the study team

2014-07-24

Who can join

Age: 21 and older, up to 45. Sex: female. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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