Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?

D. Mansour, I. S. Fraser, Alison Edelman, Carolina S. Vieira, Andrew M. Kaunitz, Tjeerd Korver, Annpey Pong, Jianxin Lin, Arvind K. Shah, Michelle Fox, Hans Rekers, Mitchell D Creinin

Research output: Contribution to journalArticle

Abstract

Objectives: To evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use. Study Design: We reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.1 starting at Day 29 and ending at Day 118. We dichotomized bleeding patterns as “favorable” (amenorrhea, infrequent bleeding and normal frequency bleeding without prolonged bleeding) or “unfavorable’ (prolonged and/or frequent bleeding) and tracked user groups based on these bleeding patterns in reference period 1.1 through Year 1 and from Year 1 through Year 2, respectively. Results: We evaluated data from 537 and 428 women with up to 1 and 2 years use, respectively. Of the 325 (60.5%) women with favorable bleeding in reference period 1.1, 275 (84.6%) reported favorable bleeding also in reference period 2, 197 (60.6%) reported favorable bleeding throughout Year 1, and favorable bleeding in 75–85% of reference periods in Year 2. Among 212 (39.5%) women with unfavorable bleeding in reference period 1.1, 118 (55.7%) continued with unfavorable bleeding in reference period 2, while about 40%–50% reported favorable patterns in RP 2, 3 and/or 4. Initial favorable bleeding resulted in lower discontinuation rates than initial unfavorable bleeding in years 1 (3.7% vs 12.7%, p≪.0001) and 2 (2.5% vs 16.5%, p≪.0001). Conclusion: Implant users with favorable bleeding in the first reference period are likely to continue with favorable bleeding over the next 2 years. Initial bleeding patterns predict overall continuation rates in years 1 and 2. Implications Statement When evaluating vaginal bleeding in any 90-day reference period over 2 years of etonogestrel implant use, approximately 80% of women with favorable and 40% with unfavorable bleeding patterns will have favorable bleeding in the next reference periods. These findings can facilitate counseling regarding bleeding for women using the etonogestrel implant.

Original languageEnglish (US)
JournalContraception
DOIs
StatePublished - Jan 1 2019

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Uterine Hemorrhage
Hemorrhage
etonogestrel

Keywords

  • Bleeding
  • Continuation
  • Etonogestrel
  • Implant

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use? / Mansour, D.; Fraser, I. S.; Edelman, Alison; Vieira, Carolina S.; Kaunitz, Andrew M.; Korver, Tjeerd; Pong, Annpey; Lin, Jianxin; Shah, Arvind K.; Fox, Michelle; Rekers, Hans; Creinin, Mitchell D.

In: Contraception, 01.01.2019.

Research output: Contribution to journalArticle

Mansour, D. ; Fraser, I. S. ; Edelman, Alison ; Vieira, Carolina S. ; Kaunitz, Andrew M. ; Korver, Tjeerd ; Pong, Annpey ; Lin, Jianxin ; Shah, Arvind K. ; Fox, Michelle ; Rekers, Hans ; Creinin, Mitchell D. / Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?. In: Contraception. 2019.
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title = "Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?",
abstract = "Objectives: To evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use. Study Design: We reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.1 starting at Day 29 and ending at Day 118. We dichotomized bleeding patterns as “favorable” (amenorrhea, infrequent bleeding and normal frequency bleeding without prolonged bleeding) or “unfavorable’ (prolonged and/or frequent bleeding) and tracked user groups based on these bleeding patterns in reference period 1.1 through Year 1 and from Year 1 through Year 2, respectively. Results: We evaluated data from 537 and 428 women with up to 1 and 2 years use, respectively. Of the 325 (60.5{\%}) women with favorable bleeding in reference period 1.1, 275 (84.6{\%}) reported favorable bleeding also in reference period 2, 197 (60.6{\%}) reported favorable bleeding throughout Year 1, and favorable bleeding in 75–85{\%} of reference periods in Year 2. Among 212 (39.5{\%}) women with unfavorable bleeding in reference period 1.1, 118 (55.7{\%}) continued with unfavorable bleeding in reference period 2, while about 40{\%}–50{\%} reported favorable patterns in RP 2, 3 and/or 4. Initial favorable bleeding resulted in lower discontinuation rates than initial unfavorable bleeding in years 1 (3.7{\%} vs 12.7{\%}, p≪.0001) and 2 (2.5{\%} vs 16.5{\%}, p≪.0001). Conclusion: Implant users with favorable bleeding in the first reference period are likely to continue with favorable bleeding over the next 2 years. Initial bleeding patterns predict overall continuation rates in years 1 and 2. Implications Statement When evaluating vaginal bleeding in any 90-day reference period over 2 years of etonogestrel implant use, approximately 80{\%} of women with favorable and 40{\%} with unfavorable bleeding patterns will have favorable bleeding in the next reference periods. These findings can facilitate counseling regarding bleeding for women using the etonogestrel implant.",
keywords = "Bleeding, Continuation, Etonogestrel, Implant",
author = "D. Mansour and Fraser, {I. S.} and Alison Edelman and Vieira, {Carolina S.} and Kaunitz, {Andrew M.} and Tjeerd Korver and Annpey Pong and Jianxin Lin and Shah, {Arvind K.} and Michelle Fox and Hans Rekers and Creinin, {Mitchell D}",
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T1 - Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?

AU - Mansour, D.

AU - Fraser, I. S.

AU - Edelman, Alison

AU - Vieira, Carolina S.

AU - Kaunitz, Andrew M.

AU - Korver, Tjeerd

AU - Pong, Annpey

AU - Lin, Jianxin

AU - Shah, Arvind K.

AU - Fox, Michelle

AU - Rekers, Hans

AU - Creinin, Mitchell D

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Objectives: To evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use. Study Design: We reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.1 starting at Day 29 and ending at Day 118. We dichotomized bleeding patterns as “favorable” (amenorrhea, infrequent bleeding and normal frequency bleeding without prolonged bleeding) or “unfavorable’ (prolonged and/or frequent bleeding) and tracked user groups based on these bleeding patterns in reference period 1.1 through Year 1 and from Year 1 through Year 2, respectively. Results: We evaluated data from 537 and 428 women with up to 1 and 2 years use, respectively. Of the 325 (60.5%) women with favorable bleeding in reference period 1.1, 275 (84.6%) reported favorable bleeding also in reference period 2, 197 (60.6%) reported favorable bleeding throughout Year 1, and favorable bleeding in 75–85% of reference periods in Year 2. Among 212 (39.5%) women with unfavorable bleeding in reference period 1.1, 118 (55.7%) continued with unfavorable bleeding in reference period 2, while about 40%–50% reported favorable patterns in RP 2, 3 and/or 4. Initial favorable bleeding resulted in lower discontinuation rates than initial unfavorable bleeding in years 1 (3.7% vs 12.7%, p≪.0001) and 2 (2.5% vs 16.5%, p≪.0001). Conclusion: Implant users with favorable bleeding in the first reference period are likely to continue with favorable bleeding over the next 2 years. Initial bleeding patterns predict overall continuation rates in years 1 and 2. Implications Statement When evaluating vaginal bleeding in any 90-day reference period over 2 years of etonogestrel implant use, approximately 80% of women with favorable and 40% with unfavorable bleeding patterns will have favorable bleeding in the next reference periods. These findings can facilitate counseling regarding bleeding for women using the etonogestrel implant.

AB - Objectives: To evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use. Study Design: We reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.1 starting at Day 29 and ending at Day 118. We dichotomized bleeding patterns as “favorable” (amenorrhea, infrequent bleeding and normal frequency bleeding without prolonged bleeding) or “unfavorable’ (prolonged and/or frequent bleeding) and tracked user groups based on these bleeding patterns in reference period 1.1 through Year 1 and from Year 1 through Year 2, respectively. Results: We evaluated data from 537 and 428 women with up to 1 and 2 years use, respectively. Of the 325 (60.5%) women with favorable bleeding in reference period 1.1, 275 (84.6%) reported favorable bleeding also in reference period 2, 197 (60.6%) reported favorable bleeding throughout Year 1, and favorable bleeding in 75–85% of reference periods in Year 2. Among 212 (39.5%) women with unfavorable bleeding in reference period 1.1, 118 (55.7%) continued with unfavorable bleeding in reference period 2, while about 40%–50% reported favorable patterns in RP 2, 3 and/or 4. Initial favorable bleeding resulted in lower discontinuation rates than initial unfavorable bleeding in years 1 (3.7% vs 12.7%, p≪.0001) and 2 (2.5% vs 16.5%, p≪.0001). Conclusion: Implant users with favorable bleeding in the first reference period are likely to continue with favorable bleeding over the next 2 years. Initial bleeding patterns predict overall continuation rates in years 1 and 2. Implications Statement When evaluating vaginal bleeding in any 90-day reference period over 2 years of etonogestrel implant use, approximately 80% of women with favorable and 40% with unfavorable bleeding patterns will have favorable bleeding in the next reference periods. These findings can facilitate counseling regarding bleeding for women using the etonogestrel implant.

KW - Bleeding

KW - Continuation

KW - Etonogestrel

KW - Implant

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