Vaginal Diseases Clinical Trial
Official title:
Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products
This open-label study will examine the disintegration/disappearance time, safety, and acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert twice: first for an in-clinic disintegration/safety assessment, and a second time for an at-home acceptability assessment, with safety assessed at the following clinic visit.
This open-label study will examine the disintegration/disappearance time, safety, and
acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert
twice: first for an in-clinic disintegration/safety assessment, and a second time for an
at-home acceptability assessment, with safety assessed at the following clinic visit.
Participants will be assigned to test their insert during either the follicular or luteal
phase of their menstrual cycle, such that the number of women who test it in the follicular
phase is approximately equal to the number who test it in the luteal phase.
Once eligibility has been confirmed, the participant will complete an in-clinic
disintegration test to estimate the amount of time required for disintegration and complete
disappearance of the vaginal insert. Prior to and following the disintegration test, the
participant will have a pelvic exam and vaginal swab(s) will be collected for development of
adherence measures. Safety will be assessed by naked eye exam and report of adverse events
(AEs).
24 to 72 hours following the in-clinic disintegration test, the participant will use the
vaginal insert at home and complete a standardized acceptability questionnaire 4 hours and
24 hours after placement. The acceptability questionnaire will be returned to the clinic at
the participant's next visit. The final clinic visit will be scheduled 24-72 hours after
placement of the vaginal insert used at home.
The final study visit will include a pelvic exam to assess safety and vaginal swab(s) will
be collected for development of adherence measures. The participant will exit the study
following the final study visit.
This study is designed to test a single placebo vaginal insert, but it is possible
additional inserts may become available for testing. Participants may re-enroll in the study
for the testing of additional vaginal inserts as they become available.
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Intervention Model: Single Group Assignment, Masking: Open Label
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