Abstract:There has been considerable advance in this field over the past three years. There is one ring currently in a Phase I clinical trial and others are soon to follow. Some of these drug delivery systems are by necessity rather complicated and hence could be prohibitively expensive in the developing world. Conducting multiple clinical trials to support regulatory approval of two or more indications represents a significant barrier. It remains unclear that women will be more motivated to use MPT products than has b… Show more
“…Multipurpose vaginal rings and new contraceptive vaginal rings in development are building upon existing technology used in NuvaRing ® to improve and control compound release [3]. While the methodology may need to be amended to fit each new product, the testing approach presented here provides a basis for applying new analytical measures of vaginal ring adherence applicable to multipurpose vaginal rings and new contraceptive vaginal rings.…”
Section: Discussionmentioning
confidence: 99%
“…Measuring adherence to PrEP regimens has relied primarily on participant self-report that can be unreliable (e.g., overreporting, recall issues, social desirability) or blood ARV concentrations that may not provide accurate measures of cumulative drug exposure over extended periods of use [2]. HIV PrEP interventions currently in development include multipurpose vaginal rings containing ARVs to prevent sexual transmission of HIV in addition to hormonal contraceptives to prevent pregnancy [3]. New analytical approaches to assess adherence to multipurpose vaginal rings are needed to better evaluate the safety and efficacy of these new intervention strategies [2,4,5].…”
Objective
This study sought to measure residual contraceptive hormone levels in vaginal rings as an adherence marker for monitoring product use in clinical trials.
Study design
Residual etonogestrel and ethinyl estradiol levels from used NuvaRings® of 26 self-reported adherent women enrolled in a clinical trial of vaginal ring acceptability were compared to those from 16 women who used NuvaRing® as their contraceptive choice.
Results
Twenty-one (81%) clinical trial rings had contraceptive hormone levels within the range of those used as a contraceptive choice. Five returned rings had unused or discordant levels of residual contraceptive hormones.
Conclusion
Residual vaginal ring drug levels could help assess adherence in clinical trials.
“…Multipurpose vaginal rings and new contraceptive vaginal rings in development are building upon existing technology used in NuvaRing ® to improve and control compound release [3]. While the methodology may need to be amended to fit each new product, the testing approach presented here provides a basis for applying new analytical measures of vaginal ring adherence applicable to multipurpose vaginal rings and new contraceptive vaginal rings.…”
Section: Discussionmentioning
confidence: 99%
“…Measuring adherence to PrEP regimens has relied primarily on participant self-report that can be unreliable (e.g., overreporting, recall issues, social desirability) or blood ARV concentrations that may not provide accurate measures of cumulative drug exposure over extended periods of use [2]. HIV PrEP interventions currently in development include multipurpose vaginal rings containing ARVs to prevent sexual transmission of HIV in addition to hormonal contraceptives to prevent pregnancy [3]. New analytical approaches to assess adherence to multipurpose vaginal rings are needed to better evaluate the safety and efficacy of these new intervention strategies [2,4,5].…”
Objective
This study sought to measure residual contraceptive hormone levels in vaginal rings as an adherence marker for monitoring product use in clinical trials.
Study design
Residual etonogestrel and ethinyl estradiol levels from used NuvaRings® of 26 self-reported adherent women enrolled in a clinical trial of vaginal ring acceptability were compared to those from 16 women who used NuvaRing® as their contraceptive choice.
Results
Twenty-one (81%) clinical trial rings had contraceptive hormone levels within the range of those used as a contraceptive choice. Five returned rings had unused or discordant levels of residual contraceptive hormones.
Conclusion
Residual vaginal ring drug levels could help assess adherence in clinical trials.
“…A vaginal ring is currently undergoing phase-I clinical trials with others soon to follow, whilst coadministration of contraceptive and HIV prevention products is also under consideration. [5] It certainly is time to take STIs seriously. Yet investments in attractive multipurpose products which meet a range of SRH needs could have more impact than vertical spending on STIs.…”
Section: Better Together? the Promise Of Multipurpose Prevention Agaimentioning
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“…Several MPT intravaginal rings containing a progestin plus
an ARV for HIV prevention (such as tenofovir or dapivirine) or a combination of
active ingredients (such as zinc acetate, carrageenan, and an ARV for simultaneous
prevention of HIV, herpes simplex virus-2, and human papillomavirus) are in
development. [4]…”
Section: Which Current and Future Products Contain Levonorgestrel?mentioning
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