A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data
| Autor: | Ndema Habib, Vivian Brache, Meirik O, Emily Jackson, Kiriwat Orawan, Kelly Culwell, Nuriye Ortayli, Johannes Schmidt, Moazzam Ali |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
medicine.medical_specialty Time Factors Pain Dentistry Levonorgestrel Intrauterine device law.invention Young Adult Randomized controlled trial law Contraceptive Agents Female Humans Medicine Etonogestrel Drug Implants Chi-Square Distribution Desogestrel business.industry Obstetrics Pruritus Obstetrics and Gynecology Intrauterine Device Expulsion Iud insertion Intrauterine Devices Copper Clinical trial Contraception Reproductive Medicine Family planning Female Implant business medicine.drug |
| Zdroj: | Contraception. 87:113-120 |
| ISSN: | 0010-7824 |
| DOI: | 10.1016/j.contraception.2012.08.044 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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