A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: Methodology and insertion data

Olav Meirik, Vivian Brache, Kiriwat Orawan, Ndema Abu Habib, Johannes Schmidt, Nuriye Ortayli, Kelly Culwell, Emily Jackson, Moazzam Ali

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background: Comparative data on etonogestrel and two-rod levonorgestrel contraceptive implants are lacking. Study Design: A multicenter, open, parallel-group trial with random allocation of implants was performed. For every second implant user, an age-matched woman choosing an intrauterine device (IUD) (TCu380A) was admitted. Methods and data on implant/IUD insertion and 6-week follow-up are reported. Results: A total of 2008 women were randomized to an implant, and 974 women were enrolled in the IUD group. Results from 997 etonogestrel implant users, 997 levonorgestrel implant users and 971 IUD users were analyzed. In the etonogestrel and levonorgestrel groups, respectively, mean insertion durations were 51 (SD 50.2) s and 88 (SD 60.8) s; complication rates at insertion were 0.8% and 0.2%; and at follow-up, 27.2% and 26.7% of women, respectively, had signs or symptoms at the insertion site. At follow-up within 6 weeks after insertion, all implants were in situ, while 2.1% of IUDs were expelled. Conclusion: Performance of etonogestrel and levonorgestrel implants at insertion and within the first 6 weeks is similar. Short-term (6 weeks) continuation rates appear higher for implants than TCu380A.

Original languageEnglish (US)
Pages (from-to)113-120
Number of pages8
JournalContraception
Volume87
Issue number1
DOIs
StatePublished - Jan 2013

Fingerprint

Copper Intrauterine Devices
Levonorgestrel
Intrauterine Devices
Contraceptive Agents
Randomized Controlled Trials
Random Allocation
Signs and Symptoms
etonogestrel

Keywords

  • Contraceptive
  • Etonogestrel
  • Implanon
  • Implant
  • Jadelle
  • Levonorgestrel
  • TCu380A

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls : Methodology and insertion data. / Meirik, Olav; Brache, Vivian; Orawan, Kiriwat; Habib, Ndema Abu; Schmidt, Johannes; Ortayli, Nuriye; Culwell, Kelly; Jackson, Emily; Ali, Moazzam.

In: Contraception, Vol. 87, No. 1, 01.2013, p. 113-120.

Research output: Contribution to journalArticle

Meirik, Olav ; Brache, Vivian ; Orawan, Kiriwat ; Habib, Ndema Abu ; Schmidt, Johannes ; Ortayli, Nuriye ; Culwell, Kelly ; Jackson, Emily ; Ali, Moazzam. / A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls : Methodology and insertion data. In: Contraception. 2013 ; Vol. 87, No. 1. pp. 113-120.
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abstract = "Background: Comparative data on etonogestrel and two-rod levonorgestrel contraceptive implants are lacking. Study Design: A multicenter, open, parallel-group trial with random allocation of implants was performed. For every second implant user, an age-matched woman choosing an intrauterine device (IUD) (TCu380A) was admitted. Methods and data on implant/IUD insertion and 6-week follow-up are reported. Results: A total of 2008 women were randomized to an implant, and 974 women were enrolled in the IUD group. Results from 997 etonogestrel implant users, 997 levonorgestrel implant users and 971 IUD users were analyzed. In the etonogestrel and levonorgestrel groups, respectively, mean insertion durations were 51 (SD 50.2) s and 88 (SD 60.8) s; complication rates at insertion were 0.8{\%} and 0.2{\%}; and at follow-up, 27.2{\%} and 26.7{\%} of women, respectively, had signs or symptoms at the insertion site. At follow-up within 6 weeks after insertion, all implants were in situ, while 2.1{\%} of IUDs were expelled. Conclusion: Performance of etonogestrel and levonorgestrel implants at insertion and within the first 6 weeks is similar. Short-term (6 weeks) continuation rates appear higher for implants than TCu380A.",
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AU - Brache, Vivian

AU - Orawan, Kiriwat

AU - Habib, Ndema Abu

AU - Schmidt, Johannes

AU - Ortayli, Nuriye

AU - Culwell, Kelly

AU - Jackson, Emily

AU - Ali, Moazzam

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AB - Background: Comparative data on etonogestrel and two-rod levonorgestrel contraceptive implants are lacking. Study Design: A multicenter, open, parallel-group trial with random allocation of implants was performed. For every second implant user, an age-matched woman choosing an intrauterine device (IUD) (TCu380A) was admitted. Methods and data on implant/IUD insertion and 6-week follow-up are reported. Results: A total of 2008 women were randomized to an implant, and 974 women were enrolled in the IUD group. Results from 997 etonogestrel implant users, 997 levonorgestrel implant users and 971 IUD users were analyzed. In the etonogestrel and levonorgestrel groups, respectively, mean insertion durations were 51 (SD 50.2) s and 88 (SD 60.8) s; complication rates at insertion were 0.8% and 0.2%; and at follow-up, 27.2% and 26.7% of women, respectively, had signs or symptoms at the insertion site. At follow-up within 6 weeks after insertion, all implants were in situ, while 2.1% of IUDs were expelled. Conclusion: Performance of etonogestrel and levonorgestrel implants at insertion and within the first 6 weeks is similar. Short-term (6 weeks) continuation rates appear higher for implants than TCu380A.

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