Contraceptive vaginal rings releasing Nestorone® and ethinylestradiol: a 1-year dose-finding trial

Sivin, Irving; Mishell, Daniel R.; Alvarez, Francisco; Brache, Vivian; Elomaa, Kaisa; Lähteenmäki, Pekka; Massai, Rebeca; Miranda, Patricia Y.; Croxatto, Horacio B.; Dean, Catherine; Small, Margaret; Nash, Harold A.; Jackanicz, Theodore M.

doi:10.1016/j.contraception.2004.08.010

Cited by 65 publications

(33 citation statements)

References 22 publications

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“…It is designed to release 150 μg NES and 15 μg EE daily and prevent pregnancy when used continuously on a 21-day-in/7-day-out cyclic regimen [1, 2]. This long-acting CVR is controlled by the woman, can be used for 13 cycles, and does not require trained healthcare provider services for insertion or removal.…”

Section: Introductionmentioning

confidence: 99%

Acceptability of the nestorone®/ethinyl estradiol contraceptive vaginal ring: development of a model; implications for introduction

et al. 2014

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Objectives Develop and test a theoretical acceptability model for the Nestorone®/ethinyl estradiol (NES/EE) contraceptive vaginal ring (CVR); explore whether domains of use within the model predict satisfaction, method adherence and CVR continuation. Study Design Four domains of use were considered relative to outcome markers of acceptability, i.e. method satisfaction, adherence, and continuation. A questionnaire to evaluate subjects’ experiences relative to the domains, their satisfaction (Likert scale), and adherence to instructions for use was developed and administered to 1036 women enrolled in a 13-cycle Phase 3 trial. Method continuation was documented from the trial database. Stepwise logistic regression (LR) analysis was conducted and odds ratios calculated to assess associations of satisfaction with questions from the 4 domains. Fisher’s exact test was used to determine the association of satisfaction with outcome measures. Results A final acceptability model was developed based on the following determinants of CVR satisfaction: ease of use, side effects, expulsions/feeling the CVR, and sexual activity including physical effects during intercourse. Satisfaction was high (89%) and related to higher method adherence [OR 2.6(1.3,5.2)] and continuation [OR5.5(3.5, 8.4)]. According to the LR analysis, attributes of CVR use representing items from the 4 domains — finding it easy to remove, not complaining of side effects, not feeling the CVR while wearing it, and experiencing no change or an increase in sexual pleasure and/or frequency — were associated with higher odds of satisfaction. Conclusion Hypothesized domains of CVR use were related to satisfaction, which was associated with adherence and continuation. Results provide a scientific basis for introduction and future research.

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Section: Introductionmentioning

confidence: 99%

Acceptability of the nestorone®/ethinyl estradiol contraceptive vaginal ring: development of a model; implications for introduction

et al. 2014

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“…In order to reach the goals of easier distribution at lower costs, the Population Council is currently developing a vaginal ring, delivering a combination of 150 mg/d of Nestorone and ethinyl-Estradiol 15 mg/day over 12 months (Sivin et al 2005). The availability of a vaginal ring that can be used over thirteen 28-day cycles has the advantage of providing a woman with a prescription for a full year of supplies, thereby reducing return visits for resupplies, and can lead to continuity of contraceptive use.…”

Section: Range Of New Methods Now Availablementioning

confidence: 99%

New vistas in contraceptive technology

RamaRao¹,

Townsend²,

Sitruk-Ware³

2008

Gender & Development

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Population forecasts predict that by 2050, about 150 million women (and couples) of child-bearing age will need contraception, and many of them are likely to find their needs unmet, due to problems of access, availability, and acceptability of the contraceptive options for one or both partners. Current contraceptive options are largely intended for use by women (pills, intrauterine devices [IUDs], injectables, and implants), with condoms and vasectomy being the only two options for men. In many countries, contraceptive use tends to be in the woman's domain, in part due to the nature of the contraceptive. This article discusses how women's health advocates have been able to raise important concerns regarding contraceptive technology and its development. It also reviews the range of new contraceptives that addresses issues of user autonomy and controllability, offers protection against pregnancy and STIs and HIV, and addresses male needs and concerns.

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“…After this preliminary study, the CVR containing NES and EE was tested [87] in 150 women and compared with three dose combinations. The mean in vitro drug release rates for the three doses were 150 and 15, 150 and 20 and 200 and 15 µg/day of NES and EE, and luteal activity was observed in 17, 7 and 12% of the women, respectively, however, without significance.…”

Section: Vaginal Contraceptionmentioning

confidence: 99%