NCT03537092

A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Katherine Bunge · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a phase I randomized trial assessing the safety of a single vaginal placebo film application. In order to develop a vaginal film which can provide extended release of an Antiretroviral (ARV), the film polymers and formulation have been altered from the cellulose and polyvinyl alcohol films used to deliver dapivirine and tenofovir in previous trials. Therefore, the proposed study will evaluate the safety and persistence of these film polymers when applied vaginally.

Detailed description

This research study will involve the use of a placebo vaginal film. Investigators want to evaluate the safety of the film and understand the acceptability and length of time for the film to dissolve once inserted into the vagina. In future studies, this film may have medication added to it to deliver medication over an extended period of time (i.e. extended release). All of the eligible women will be randomized (distributed by chance, like rolling a dice) at the Enrollment Visit to one of four study groups. The groups will specify what day Visit 3 will be performed. Participants will have an equal likelihood of being in any one of the four groups. Neither the participant nor the study staff can choose the group or can change the group the participant has been placed into. Regardless of which group the participant is in she will only use the film once during the study. Women in all of the study groups will have the same study visit schedule except for the timing of Visit 3.

Conditions

• Safety of Vaginal Film Use

Interventions

Type	Name	Description
DEVICE	Vaginal Film	2" x 2" vaginal film with no active drug

Timeline

• Start date: 2018-05-22
• Primary completion: 2018-12-04
• Completion: 2018-12-04
• First posted: 2018-05-25
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study