Factors associated with nonadherence to instructions for using the Nestorone®/ethinyl estradiol contraceptive vaginal ring

Bianca M. Stifani, Marlena Plagianos, Carolina Sales Vieira, Ruth B. Merkatz

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Objectives: We sought to identify factors associated with nonadherence to instructions for using a novel contraceptive providing 1 year of protection. Study design: Data from a multicountry Phase 3 trial of the Nestorone® (segesterone acetate)/ethinyl estradiol (NES/EE) contraceptive vaginal ring (CVR) were analyzed. Participants were instructed to use the CVR over 13 cycles and follow a 21/7 regimen. Their reports of CVR removals >2 h outside scheduled removal periods served as a proxy for nonadherence. We used multivariate logistic regression to determine factors associated with such use. Results: Of 905 participants, 120 (13%) reported CVR removals >2 h. Removals for washing [odds ratio (OR) 3.96, 95% confidence interval (CI) 2.50–6.27] or sexual intercourse (OR 3.19, 95% CI 2.03–4.99), and finding CVR insertion difficult (OR 2.80, 95% CI 1.36–5.80) were factors associated with removals >2 h. Lower educational attainment also predicted ring removal >2 h (OR 3.23, 95% CI 1.55–6.75). Women residing in Europe or Australia were less likely to remove the ring for >2 h compared with women in the United States (OR 0.44, 95% CI 0.24–0.83 and OR 0.13, 95% CI 0.02–0.98, respectively). Participants who reported removals >2 h were more likely to discontinue CVR use (OR 1.93, 95% CI 1.24–2.95), report dissatisfaction (OR 2.20, 95% CI 1.32–3.69) and become pregnant during the study (OR 4.07, 95% CI 1.58–10.50). Conclusions: Removing the CVR for washing and removing it before intercourse are factors associated with nonadherence to ring use. These are important topics for counseling women who are considering or using vaginal rings, including the NES/EE CVR. Implications: Findings from this study may be useful in guiding counseling for current and prospective vaginal ring users. Anticipatory guidance should focus on how the ring feels in the vagina and during sex. Asking about ring removals may help identify women who are at increased risk for having an unplanned pregnancy.

Original languageEnglish (US)
Pages (from-to)415-421
Number of pages7
JournalContraception
Volume97
Issue number5
DOIs
StatePublished - May 2018

Fingerprint

Female Contraceptive Devices
Ethinyl Estradiol
Contraceptive Agents
Odds Ratio
Confidence Intervals
Counseling
Acetates
ST 1435
Unplanned Pregnancy
Coitus
Proxy
Vagina
Logistic Models

Keywords

  • Acceptability
  • Adherence
  • Contraception
  • Vaginal ring

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Factors associated with nonadherence to instructions for using the Nestorone®/ethinyl estradiol contraceptive vaginal ring. / Stifani, Bianca M.; Plagianos, Marlena; Vieira, Carolina Sales; Merkatz, Ruth B.

In: Contraception, Vol. 97, No. 5, 05.2018, p. 415-421.

Research output: Contribution to journalArticle

Stifani, Bianca M. ; Plagianos, Marlena ; Vieira, Carolina Sales ; Merkatz, Ruth B. / Factors associated with nonadherence to instructions for using the Nestorone®/ethinyl estradiol contraceptive vaginal ring. In: Contraception. 2018 ; Vol. 97, No. 5. pp. 415-421.
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abstract = "Objectives: We sought to identify factors associated with nonadherence to instructions for using a novel contraceptive providing 1 year of protection. Study design: Data from a multicountry Phase 3 trial of the Nestorone{\circledR} (segesterone acetate)/ethinyl estradiol (NES/EE) contraceptive vaginal ring (CVR) were analyzed. Participants were instructed to use the CVR over 13 cycles and follow a 21/7 regimen. Their reports of CVR removals >2 h outside scheduled removal periods served as a proxy for nonadherence. We used multivariate logistic regression to determine factors associated with such use. Results: Of 905 participants, 120 (13{\%}) reported CVR removals >2 h. Removals for washing [odds ratio (OR) 3.96, 95{\%} confidence interval (CI) 2.50–6.27] or sexual intercourse (OR 3.19, 95{\%} CI 2.03–4.99), and finding CVR insertion difficult (OR 2.80, 95{\%} CI 1.36–5.80) were factors associated with removals >2 h. Lower educational attainment also predicted ring removal >2 h (OR 3.23, 95{\%} CI 1.55–6.75). Women residing in Europe or Australia were less likely to remove the ring for >2 h compared with women in the United States (OR 0.44, 95{\%} CI 0.24–0.83 and OR 0.13, 95{\%} CI 0.02–0.98, respectively). Participants who reported removals >2 h were more likely to discontinue CVR use (OR 1.93, 95{\%} CI 1.24–2.95), report dissatisfaction (OR 2.20, 95{\%} CI 1.32–3.69) and become pregnant during the study (OR 4.07, 95{\%} CI 1.58–10.50). Conclusions: Removing the CVR for washing and removing it before intercourse are factors associated with nonadherence to ring use. These are important topics for counseling women who are considering or using vaginal rings, including the NES/EE CVR. Implications: Findings from this study may be useful in guiding counseling for current and prospective vaginal ring users. Anticipatory guidance should focus on how the ring feels in the vagina and during sex. Asking about ring removals may help identify women who are at increased risk for having an unplanned pregnancy.",
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N2 - Objectives: We sought to identify factors associated with nonadherence to instructions for using a novel contraceptive providing 1 year of protection. Study design: Data from a multicountry Phase 3 trial of the Nestorone® (segesterone acetate)/ethinyl estradiol (NES/EE) contraceptive vaginal ring (CVR) were analyzed. Participants were instructed to use the CVR over 13 cycles and follow a 21/7 regimen. Their reports of CVR removals >2 h outside scheduled removal periods served as a proxy for nonadherence. We used multivariate logistic regression to determine factors associated with such use. Results: Of 905 participants, 120 (13%) reported CVR removals >2 h. Removals for washing [odds ratio (OR) 3.96, 95% confidence interval (CI) 2.50–6.27] or sexual intercourse (OR 3.19, 95% CI 2.03–4.99), and finding CVR insertion difficult (OR 2.80, 95% CI 1.36–5.80) were factors associated with removals >2 h. Lower educational attainment also predicted ring removal >2 h (OR 3.23, 95% CI 1.55–6.75). Women residing in Europe or Australia were less likely to remove the ring for >2 h compared with women in the United States (OR 0.44, 95% CI 0.24–0.83 and OR 0.13, 95% CI 0.02–0.98, respectively). Participants who reported removals >2 h were more likely to discontinue CVR use (OR 1.93, 95% CI 1.24–2.95), report dissatisfaction (OR 2.20, 95% CI 1.32–3.69) and become pregnant during the study (OR 4.07, 95% CI 1.58–10.50). Conclusions: Removing the CVR for washing and removing it before intercourse are factors associated with nonadherence to ring use. These are important topics for counseling women who are considering or using vaginal rings, including the NES/EE CVR. Implications: Findings from this study may be useful in guiding counseling for current and prospective vaginal ring users. Anticipatory guidance should focus on how the ring feels in the vagina and during sex. Asking about ring removals may help identify women who are at increased risk for having an unplanned pregnancy.

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