Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations
Condition: Safety; Acceptability
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      This is a double-blinded crossover study to evaluate whether ammonio methacrylate copolymer
      dispersion type B (Eudragit®) content impacts the ability to self-insert placebo vaginal
      films. Eudragit® is a commonly used pharmaceutical excipient, present in several FDA approved
      products. This hydrophobic excipient is used in vaginal film formulations to increase
      disintegration time and impart extended drug release property. The presence of Eudragit and
      its concentration level affects film disintegration and spreadability in the vaginal
      environment, and are likely to affect tactile properties. Consequently, these attributes may
      impact ease of film administration, acceptability, and user preferences for specific film
      type.

      Thirty pre-menopausal women, 18 - 45 years of age, will self-insert one high and and one low
      Eudragit® content film. High and low Eudragit films correspond to 12.8% and 6.4% of Eudragit®
      added during the formulation blending stage. The insertion order will be randomized in a 1:1
      ratio. Within 10 minutes of the insertion, clinical staff will perform a speculum exam to
      assess the location of the film and remove the residual film. 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.
    

Intervention name(s): High Eudragit® Content Vaginal Film; Low Eudragit® Content Vaginal Film
Intervention type(s): Device; Device
Intervention description(s): High (12.8%) Eudragit® Content Vaginal Film; Low (6.4%) Eudragit® Content Vaginal Film
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant will self-insert one low level Eudragit® and one high level Eudragit® formulation film. The sequence of insertion will be randomized in a 1:1 ratio.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: Vagina; Film; Extended Release