Post-use ring weight and residual drug content as potential objective measures of user adherence to a contraceptive progesterone vaginal ring
| Autor: | Clare McCoy, R. Karl Malcolm, Diarmaid J. Murphy, Marlena Gehret Plagianos, Heather Clark, Bruce Variano, Peter Boyd, Saumya RamaRao, Ruth Merkatz |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Urology Nigeria Residual Ring (chemistry) 03 medical and health sciences 0302 clinical medicine Linear regression Contraceptive Agents Female Humans Medicine 030212 general & internal medicine Progesterone Clinical Trials as Topic 030219 obstetrics & reproductive medicine business.industry Contraceptive Devices Female Obstetrics and Gynecology Kenya Vaginal ring Senegal Drug content Reproductive Medicine Linear Models Patient Compliance Female business Linear trend |
| Zdroj: | Contraception. 100:241-246 |
| ISSN: | 0010-7824 |
| DOI: | 10.1016/j.contraception.2019.06.013 |
| Popis: | Objectives The primary aim was to investigate post-use ring weight as a potential measure of cumulative adherence to a progesterone-releasing vaginal ring. Study design We weighed and quantified residual progesterone in 115 vaginal rings following 90-day use by participants in an acceptability trial conducted in Nigeria, Senegal and Kenya. The primary objective was to correlate residual progesterone content with post-use ring weight. Secondary objectives included correlating ring weight with putative duration of ring use, and, where participants used two rings consecutively in the study, correlating residual content between these paired rings. Results Mean ring weight and progesterone content of used rings was 8.62±0.24 g and 1245±245 mg respectively, versus 9.37±0.02 and 2058±21 mg for control rings. Most used rings (90.4%) had residual progesterone levels less than 85% of the nominal loading. Linear regression showed a strong positive linear trend between residual progesterone content and post-use ring weight for all rings (r2=0.82). Duration of ring use was inversely associated (p=.00020) with ring weight. Conclusions Post-use ring weight is highly correlated with residual progesterone content, a benchmark objective cumulative measure of adherence, and thus potentially useful as a surrogate objective measure of cumulative adherence to a progesterone-releasing vaginal ring. Implication statement For vaginal rings containing a high initial drug loading and releasing a relatively large fraction of the initial loading during clinical use, post-use ring weight may offer a simple and inexpensive alternative to residual content testing for accurate monitoring of user adherence. |
| Databáze: | OpenAIRE |
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