Abstract | OBJECTIVES: 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.
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Authors | Diana Mansour, Ian 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 |
Journal | Contraception
(Contraception)
Vol. 100
Issue 4
Pg. 264-268
(10 2019)
ISSN: 1879-0518 [Electronic] United States |
PMID | 31176688
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study)
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Copyright | Crown Copyright © 2019. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Contraceptive Agents, Female
- Drug Implants
- etonogestrel
- Desogestrel
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Topics |
- Adult
- Amenorrhea
(chemically induced)
- Chile
- Contraceptive Agents, Female
(adverse effects)
- Desogestrel
(adverse effects)
- Drug Implants
(adverse effects)
- Europe
- Female
- Humans
- Menstruation
(drug effects)
- Time Factors
- United States
- Young Adult
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