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A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data.
Contraception 2013; 87(1):113-20C

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.

Authors+Show Affiliations

UNDP, UNFPA, WHO, World Bank Special Programme of Research Development and Reaserch Training in Human Reproduction, Geneva, Switzerland. meiriko@icmer.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23063337

Citation

Meirik, Olav, et al. "A Multicenter Randomized Clinical Trial of One-rod Etonogestrel and Two-rod Levonorgestrel Contraceptive Implants With Nonrandomized copper-IUD Controls: Methodology and Insertion Data." Contraception, vol. 87, no. 1, 2013, pp. 113-20.
Meirik O, Brache V, Orawan K, et al. A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data. Contraception. 2013;87(1):113-20.
Meirik, O., Brache, V., Orawan, K., Habib, N. A., Schmidt, J., Ortayli, N., ... Ali, M. (2013). A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data. Contraception, 87(1), pp. 113-20. doi:10.1016/j.contraception.2012.08.044.
Meirik O, et al. A Multicenter Randomized Clinical Trial of One-rod Etonogestrel and Two-rod Levonorgestrel Contraceptive Implants With Nonrandomized copper-IUD Controls: Methodology and Insertion Data. Contraception. 2013;87(1):113-20. PubMed PMID: 23063337.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data. AU - Meirik,Olav, 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, AU - ,, Y1 - 2012/10/10/ PY - 2012/03/29/received PY - 2012/08/30/revised PY - 2012/08/30/accepted PY - 2012/10/16/entrez PY - 2012/10/16/pubmed PY - 2013/6/6/medline SP - 113 EP - 20 JF - Contraception JO - Contraception VL - 87 IS - 1 N2 - 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. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/23063337/A_multicenter_randomized_clinical_trial_of_one_rod_etonogestrel_and_two_rod_levonorgestrel_contraceptive_implants_with_nonrandomized_copper_IUD_controls:_methodology_and_insertion_data_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(12)00810-4 DB - PRIME DP - Unbound Medicine ER -