Extended use up to 5 years of the etonogestrel-releasing subdermal contraceptive implant: comparison to levonorgestrel-releasing subdermal implant

Abstract

STUDY QUESTIONIs it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years?SUMMARY ANSWERThe extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5.WHAT IS KNOWN ALREADYThe initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks.STUDY DESIGN SIZE, DURATIONFor the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan–Meier (K–M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes.PARTICIPANTS/MATERIALS, SETTING, METHODSThe study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively.MAIN RESULTS AND THE ROLE OF CHANCEOver 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K–M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2–1.8] and 0.8 per 100 W-Y [95% CI: 0.2–2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p < 0.05). The median duration of the implant removal procedure was 64 seconds shorter for the one-rod ENG-implant (inter-quartile range (IQR) = 30.5, 117.5) compared to the two-rod LNG product (IQR = 77.0, 180.0). The 2-year rate for pregnancy in the IUD group compared with the two implant groups combined was 4.1 per 100 W-Y [95% CI: 2.5–6.5].LIMITATIONS, REASONS FOR CAUTIONFew women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few.WIDER IMPLICATIONS OF THE FINDINGSThe results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the product's capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal impla...

Strengthening implant provision and acceptance in South Africa with the ‘Any woman, any place, any time’ approach: An essential step towards reducing unintended pregnancies

“…[37][38][39] Jadelle and a similar device, the Sino-implant, have fewer bleeding side-effects than Implanon. [13,37,40,41] Continuation rates were also better with Jadelle than Implanon in several studies, [37,41] but not in a multi-country randomised trial. [40] Women should be given written information, providing further explanation of changes in bleeding patterns that could be antici pated and the possibilities of treatment for these.…”

“…[10,11] In SA, Implanon is currently used to provide pregnancy protection for 3 years, but increasingly evidence suggests that protection may extend to 5 years, even in women with a high body mass index. [12,13] Prolonged effectiveness would further improve Implanon's convenience for women, and reduce removal procedures and costs of implant replacements.…”

Prolonged use of the etonogestrel implant and levonorgestrel intrauterine device: 2 years beyond Food and Drug Administration–approved duration

“…Likewise, this cohort now includes more than 250 woman-years of use for 2 additional years, demonstrating continued efficacy and consistent with recent data published by the World Health Organization. 6 …”

“…2–5 Data from the World Health Organization (WHO) study group on the subdermal implant recently published findings in which there were no documented pregnancies in women using the ENG implant during years 4 and 5. 6 We have found scant data in the medical literature for contraceptive effectiveness beyond 6 years for the LNG-IUD.…”

Long-Acting Reversible Contraception

“…50 A multicountry study showed no pregnancies among 204 implant users during the fourth and fifth years of use. 52 The serum etonogestrel levels remained within the thresholds of contraceptive effectiveness for the implant through 4 years of follow-up and did not vary significantly according to body-mass index. 50 A longer period of effectiveness would decrease the need for removal and reinsertion procedures.…”