Multiple use applicator for vaginal tablets/vaginal inserts: compliance verification and suitability studies.

ABSTRACT:

Background

A newly developed multiple use applicator for vaginal tablets/vaginal inserts* was evaluated for its general suitability. There are no standard procedures described in guidelines or general accepted publications as to how this kind of product should be tested for suitability of purpose.

Methods

Due to the lack of existing standard procedures, three separate tests were designed and successful executed: (a) First, a patient acceptability evaluation was carried out as part of a phase III trial (registered in EudraCT on 9 Jan 2017, number 2017-000142-22 2. https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number%3A2017-000142-22 ). (b) Secondly, a cleaning procedure for the applicator after simulated multiple use was developed and verified in order

SUBMITTER: Brunner H 

PROVIDER: S-EPMC7558499 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature