A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant
| Autor: | Paula Briggs, Dan Apter, Kristina Gemzell-Danielsson, Sarah Rybowski, Julia Grunert, Eeva Lukkari-Lax, Marjo Tuppurainen |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
endocrine system medicine.medical_specialty Time Factors Adolescent Levonorgestrel Subdermal implant law.invention Young Adult 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Pregnancy Desogestrel law Contraceptive Agents Female medicine Humans 030212 general & internal medicine Etonogestrel Drug Implants 030219 obstetrics & reproductive medicine business.industry Intrauterine Devices Medicated Pregnancy Unplanned Obstetrics and Gynecology Contraceptives Oral Synthetic Confidence interval Menstruation Surgery Discontinuation Europe Treatment Outcome Reproductive Medicine Patient Satisfaction Female Implant business medicine.drug |
| Zdroj: | Fertility and Sterility. 106:151-157.e5 |
| ISSN: | 0015-0282 |
| DOI: | 10.1016/j.fertnstert.2016.02.036 |
| Popis: | Objective To compare the levonorgestrel intrauterine system (LNG-IUS 8), which has an average levonorgestrel release rate of ∼8 μg/24 hours during the first year (total levonorgestrel content 13.5 mg; Jaydess/Skyla), with the etonogestrel (ENG) subdermal implant (total content, 68 mg) with regard to the 12-month discontinuation rate (primary outcome). Design Randomized, open-label, phase III study. Setting Thirty-eight centers in six European countries. Patient(s) Study population of 766 healthy nulliparous and parous women aged 18–35 years. Intervention(s) The LNG-IUS 8 or the ENG implant. Main Outcome Measure(s) Discontinuation rate, by treatment group, at Month 12. Result(s) The 12-month discontinuation rates were 19.6% and 26.8% in the LNG-IUS 8 and ENG implant groups, respectively. The −7.2% difference was statistically significant (95% confidence interval −13.2%, −1.2%). Fewer women in the LNG-IUS 8 group than in the ENG implant group discontinued because of increased bleeding (3.2% vs. 11.3%) or adverse events (14.3% vs. 21.8%). At 12 months, more women in the LNG-IUS 8 group than in the ENG implant group were "very/somewhat satisfied" with their bleeding pattern (60.9% vs. 33.6%) and reported a preference to use their study treatment after study completion (70.1% vs. 58.5%). Conclusion(s) The LNG-IUS 8 was associated with a significantly lower 12-month discontinuation rate compared with the ENG implant; mainly because ENG implant users frequently discontinued due to increased bleeding. More LNG-IUS 8 users than ENG implant users reported being "very/somewhat satisfied" with their bleeding pattern, and reported a preference to continue using their study treatment after the study. Clinical Trial Registration Number NCT01397097. |
| Databáze: | OpenAIRE |
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