A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data.
BACKGROUND
Comparative data on etonogestrel and two-rod levonorgestrel contraceptive implants are lacking.


METHODS
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.


CONCLUSIONS
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.
UNDP, UNFPA, WHO, World Bank Special Programme of Research Development and Reaserch Training in Human Reproduction, Geneva, Switzerland. meiriko@icmer.org
Olav
O
Meirik
Vivian
V
Brache
Kiriwat
K
Orawan
Ndema Abu
NA
Habib
Johannes
J
Schmidt
Nuriye
N
Ortayli
Kelly
K
Culwell
Emily
E
Jackson
Moazzam
M
Ali
D000328:Adult; D016009:Chi-Square Distribution; D003267:Contraception / Q000379:methods; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D017135:Desogestrel / Q000008:administration & dosage* / Q000009:adverse effects; D004343:Drug Implants / Q000009:adverse effects; D005260:Female; D006801:Humans; D007433:Intrauterine Device Expulsion; D007435:Intrauterine Devices, Copper; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D010146:Pain / Q000139:chemically induced; D011537:Pruritus / Q000139:chemically induced; D013997:Time Factors; D055815:Young Adult
D003271:Contraceptive Agents, Female; D004343:Drug Implants; C044815:etonogestrel; D016912:Levonorgestrel; D017135:Desogestrel