Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2020
This is a double-blinded crossover study to evaluate whether Eudragit® content impacts the ability to self-insert placebo vaginal films. Thirty women will self-insert one high and and one low Eudragit® content film. The insertion order will be randomized in a 1:1 ratio. After inserting each film, participants will complete a survey reporting their perceptions and experience. The primary endpoint is successful insertion defined as all of the film inside the vagina upon visual assessment by a study clinician. Secondary outcomes include preference for the low level or high level Eudragit® formulation film with respect to insertion and participants\' description of identified challenges.
Epistemonikos ID: ad6eff42ded3ea3cb2dba6d7063c6f3b5f0bf3f6
First added on: May 07, 2024