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| Motta, Antonella |
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| Mohamed, Tarek |
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| Ertürk, Emre |
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| Petrov, R. H. | Madrid |
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| Alshaaer, Mazen | Brussels |
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| Azevedo, Nuno Monteiro |
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Variano, Bruce
in Cooperation with on an Cooperation-Score of 37%
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article
Post-use ring weight, residual drug content and drug depletion zone thickness as objective measures of user adherence to a contraceptive progesterone vaginal ring
Abstract
Objectives:<br/>A major challenge in the development of drug-releasing vaginal rings is the accurate and reliable measurement of adherence in clinical trials. In efforts to move away from reliance on self-reported measures of adherence, there is considerable interest in the development and testing of more objective quantitative measures. Here, we assessed post-use ring weight, residual drug content and drug depletion zone thickness as potential cumulative measures of adherence to a progesterone-releasing ring.<br/><br/>Study design:<br/>Progesterone-releasing rings (n=115) used by women across three sites in Africa were assessed for ring weight, residual progesterone content (via solvent extraction and HPLC-UV analysis), and drug depletion zone thickness (using digital microscopy) as potential measures of user adherence. <br/><br/>Results:<br/>Unused control rings (n=6) had mean progesterone content of 2058 ± 21 mg (99.2 ± 1.0 %; relative to 2074 mg nominal loading) and ring weight of 9.372 ± 0.016 g. Mean residual progesterone content and post-use ring weight for clinical rings were 1245 ± 245 mg and 8.6 ± 0.2 g, respectively. Wide variations in residual progesterone content (range 45.0–100% of controls) and ring weight (range 87.9–100.3%) of used rings were attributed to differences in extent of ring use. Linear correlations were observed between residual progesterone content and post-use ring weight (r2=0.8244), and thickness of the drug depletion zone with post-use ring weight (r2=0.9757) and residual drug content (r2=0.9743).<br/><br/>Conclusions:<br/>Post-use ring weight, residual progesterone content and depletion zone thickness are potentially useful as objective cumulative measures of adherence to a progesterone-releasing vaginal ring. <br/>