Examining the efficacy, safety, and patient acceptability of the combined contraceptive vaginal ring (NuvaRing&amp;reg;)

Wieder, Devorah R; Pattimakiel, Lynn

doi:10.2147/ijwh.s6162

Cited by 55 publications

(49 citation statements)

References 45 publications

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“…The excess of undissolved and highly mobile TFV in the tubing lumen allowed for true time-independent TFV release until virtually the entire load was depleted, thus minimizing drug waste. Conventional solid-core polymeric reservoir IVRs, such as NuvaRing, create environmental and cost concerns since up to 85% of the initial drug load remains in the IVR at the end of its planned duration (60).…”

Section: Discussionmentioning

confidence: 99%

A 90-Day Tenofovir Reservoir Intravaginal Ring for Mucosal HIV Prophylaxis

Johnson

Clark

Albright

et al. 2012

Antimicrob Agents Chemother

117

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A vaginal gel containing the antiretroviral tenofovir (TFV) recently demonstrated 39% protection against HIV infection in women. We designed and evaluated a novel reservoir TFV intravaginal ring (IVR) to potentially improve product effectiveness by providing a more controlled and sustained vaginal dose to maintain cervicovaginal concentrations. Polyurethane tubing of various hydrophilicities was filled with a high-density TFV/glycerol/water semisolid paste and then end-sealed to create IVRs. In vitro, TFV release increased with polyurethane hydrophilicity, with 35 weight percent water-swelling polyurethane IVRs achieving an approximately 10-mg/day release for 90 days with mechanical stiffness similar to that of the commercially available NuvaRing. This design was evaluated in two 90-day in vivo sheep studies for TFV pharmacokinetics and safety. Overall, TFV vaginal tissue, vaginal fluid, and plasma levels were relatively time independent over the 90-day duration at approximately 10 4 ng/g, 10 6 ng/g, and 10 1 ng/ml, respectively, near or exceeding the highest observed concentrations in a TFV 1% gel control group. TFV vaginal fluid concentrations were approximately 1,000-fold greater than levels shown to provide significant protection in women using the TFV 1% gel. There were no toxicological findings following placebo and TFV IVR treatment for 28 or 90 days, although slight to moderate increases in inflammatory infiltrates in the vaginal epithelia were observed in these animals compared to naïve animals. In summary, the controlled release of TFV from this reservoir IVR provided elevated sheep vaginal concentrations for 90 days to merit its further evaluation as an HIV prophylactic. R ecent progress in antiretroviral HIV prevention research has advanced the field from concept toward medical practice (46). The CAPRISA 004 study demonstrated that a vaginal gel containing the reverse transcriptase inhibitor tenofovir (TFV) was partially effective in preventing HIV transmission in women (1), with significant protection observed in women who maintained preventative TFV concentrations of at least 1,000 ng/ml in vaginal fluid (23). However, the overall effectiveness (39%) was likely reduced by poor user adherence to the inconvenient before-andafter-sex dosing regimen. The correlation of adherence and TFV vaginal fluid concentrations to protection was a key finding (23,24), indicating the need for vaginal drug delivery systems that attain and maintain elevated user adherence and vaginal drug concentrations. More recently, the VOICE trial tested the same TFV 1% gel formulation as CAPRISA 004 but with a once-daily dosage regimen and failed to show any effectiveness in women. Here, as well, low adherence may have contributed to the gel's inability to prevent HIV transmission (54). As a result, we (6, 21) and others (4,35,36,44,49) aim to develop TFV drug delivery systems to provide sustained protective vaginal tissue concentrations and potentially increase user adherence.The micromolar anti-HIV activity of TFV motivated sel...

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Section: Discussionmentioning

confidence: 99%

A 90-Day Tenofovir Reservoir Intravaginal Ring for Mucosal HIV Prophylaxis

Johnson

Clark

Albright

et al. 2012

Antimicrob Agents Chemother

117

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“…As ring development continues, complementary behavioral science research can provide valuable insight into strategies for optimizing ring uptake and long‐term use among women who would benefit from single‐ or multipurpose prevention technologies. Overall, studies show that contraceptive vaginal rings are well‐tolerated by and highly acceptable to women . In studies that have compared them to oral contraceptive pills, rings have yielded similar rates of acceptability and higher rates of continuation and adherence .…”

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confidence: 98%

“…Overall, studies show that contraceptive vaginal rings are well-tolerated by and highly acceptable to women. 17,18 In studies that have compared them to oral contraceptive pills, rings have yielded similar rates of acceptability and higher rates of continuation and adherence. 9, [19][20][21] In clinical and intervention trials, most women were satisfi ed with investigational rings (>80%) and were willing to recommend them to a friend (>90%).…”

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confidence: 99%

A Qualitative Systematic Review of Women's Experiences Using Contraceptive Vaginal Rings: Implications for New Technologies

Vargas

Midoun

Guillen

et al. 2019

Perspect Sexual Reproductive

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CONTEXT Vaginal rings are available for contraception and hormone replacement, and are being developed as HIV/STD or multipurpose prevention technologies. A comprehensive understanding of women's expectations of and experiences with rings is urgently needed to inform product development and to optimize ring use. METHODS Three databases (PubMed, Global Health and CINAHL) were searched for English‐language, peer‐reviewed articles published between January 1996 and November 2017 that reported qualitative data on barriers to and facilitators of use of female‐controlled contraceptive methods. Data on study methods, findings and conclusions pertaining to contraceptive rings were extracted, organized and analyzed. RESULTS Twenty‐six articles, all published since 2008, met the inclusion criteria. Seven studies focused largely or entirely on rings (and involved current, former or potential users), while the others focused on other contraceptive methods but included ring‐specific data. Familiarity with the ring was low, and women commonly had initial concerns about the method—often related to insertion and removal, cleanliness and discomfort with touching their vagina—that were typically overcome over time. Other major themes were issues related to ring use and discontinuation, the importance of ring‐related properties and characteristics, and considerations related to sexual partners and health care providers. CONCLUSIONS Qualitative data have the potential to inform ring design and promotion. Future research should further explore women's expectations and experiences with the ring, the value of involving male partners in ring evaluation, and evaluation of interventions to improve patient–provider communication concerning ring choice and use.

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“…In recent years, contraceptive vaginal rings have gained popularity over oral contraceptives as they offer the advantages of vaginal route of administration: avoiding intestinal unreliable absorption and hepatic first-pass metabolism, allowing a constant release with lower systemic exposure whilst maintaining contraceptive efficacy [1,2]. Other additional benefits as being discreet, well tolerated and monthly applied, contributes to the increased user compliance.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetic bioequivalence, safety and acceptability of Ornibel^®, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring^® (etonogestrel/ethinylestradiol 11.7/2.7 mg)

Algorta

Diaz

Benito

et al. 2017

The European Journal of Contraception & Reproductive Health

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Examining the efficacy, safety, and patient acceptability of the combined contraceptive vaginal ring (NuvaRing®)

Cited by 55 publications

References 45 publications

A 90-Day Tenofovir Reservoir Intravaginal Ring for Mucosal HIV Prophylaxis

A 90-Day Tenofovir Reservoir Intravaginal Ring for Mucosal HIV Prophylaxis

A Qualitative Systematic Review of Women's Experiences Using Contraceptive Vaginal Rings: Implications for New Technologies

Pharmacokinetic bioequivalence, safety and acceptability of Ornibel^®, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring^® (etonogestrel/ethinylestradiol 11.7/2.7 mg)

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Examining the efficacy, safety, and patient acceptability of the combined contraceptive vaginal ring (NuvaRing&reg;)

Cited by 55 publications

References 45 publications

A 90-Day Tenofovir Reservoir Intravaginal Ring for Mucosal HIV Prophylaxis

A 90-Day Tenofovir Reservoir Intravaginal Ring for Mucosal HIV Prophylaxis

A Qualitative Systematic Review of Women's Experiences Using Contraceptive Vaginal Rings: Implications for New Technologies

Pharmacokinetic bioequivalence, safety and acceptability of Ornibel®, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring® (etonogestrel/ethinylestradiol 11.7/2.7 mg)

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Product

Resources

About

Examining the efficacy, safety, and patient acceptability of the combined contraceptive vaginal ring (NuvaRing®)

Pharmacokinetic bioequivalence, safety and acceptability of Ornibel^®, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring^® (etonogestrel/ethinylestradiol 11.7/2.7 mg)