Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products
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|ClinicalTrials.gov Identifier: NCT02534779|
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : June 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Diseases||Other: Placebo Vaginal Insert||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Placebo Vaginal Insert
Other: Placebo Vaginal Insert
- Time to disintegration (insert no longer coherent but residual product is visible) [ Time Frame: Up to 90 minutes post-insertion ]
- Percent of inserts that partially/fully disintegrate and completely disappear at each time point of observation [ Time Frame: Up to 90 minutes post use ]
- Time to complete disappearance [ Time Frame: Up to 90 minutes post-insertion ]
- Abnormal findings related to study product on pelvic examination by naked eye exam [ Time Frame: Up to 90 minutes post use; 24-72 hours post at-home use ]
- Genitourinary adverse events after use of inserts [ Time Frame: Up to 90 minutes post use; 24-72 hours post at-home use ]
- Responses on acceptability questionnaire after a single use of a vaginal insert [ Time Frame: 4 hours and 24 hours post at-home use ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534779
|United States, Virginia|
|Eastern Virginia Medical School|
|Norfolk, Virginia, United States, 23507|
|Study Chair:||Jill Schwartz, MD||CONRAD|