NCT02908503

Vaginal Film Administration and Placement Study: FLAG

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate use of four different vaginal films - two sizes and two textures. The vaginal films have no active ingredients or medications. Information will be gathered about each film (i.e. ease of insertion, proper placement, opinions about each). The results of this study will help investigators determine which type of vaginal film to use (and how to write product instructions) for future studies.

Detailed description

All women will use all 4 products in a randomized study design with a crossover evaluation during 10 visits over two months. Visits will be scheduled when the participant is not menstruating/bleeding. The sequence of film use will be randomized. Study procedures will involve a screening visit (VISIT 1) during which a baseline cervicovaginal lavage will be collected and infections will be excluded. After randomization (VISIT 2) women will be given instructions and instructed to insert the first film. An external genital examination will be performed after the participant inserts the film to verify film placement. In the event a participant has difficulty placing the film, the study clinician may place the film for them. Following each film insertion, a questionnaire will be administered to obtain feedback regarding ease of administration. Thirty minutes after product insertion a clinician will visualize film placement in the vagina by speculum examination. Women will be counseled to avoid sexual activity or vaginal product usage before VISIT 3 scheduled for the following day. At visit 3 women will have a speculum examination to assess whether the film has completed disintegrated and a CVL sample will be collected. Women will be given an appointment for the next film insertion in 7-20 days. The general sequence of events will be repeated for each subsequent film. At the next visit (VISIT 4) women will insert the second film and have the same evaluation as visit 2. A CVL sample will be collected 24 hours later (VISIT 5). Women will be asked to return to insert another film 7-20 days later (VISIT 6) and a CVL sample will be collected the next day (VISIT 7). Women will receive the final film 7-20 days later (VISIT 8) and have the final CVL collection following film insertion the next day (VISIT 9). A final visit (VISIT 10) will be scheduled \>14 days after visit 9. During this visit a CVL will be collected for glycomic and innate antiviral activity studies and an in depth interview will be conducted in order to gain insights into the role of film polymer and size on perceived ease of insertion across the four film types.

Conditions

• Healthy Women

Interventions

Type	Name	Description
OTHER	Placebo Film	placebo vaginal films

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-02-14
• Completion: 2017-02-14
• First posted: 2016-09-21
• Last updated: 2018-07-05

Locations

1 site across 1 country: United States