Anita Nelson1, Dan Apter, Brian Hauck, Thomas Schmelter, Sarah Rybowski, Kimberly Rosen, Kristina Gemzell-Danielsson. 1. Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, California; the Sexual Health Clinic (Family Federation of Finland), Väestöliitto, Helsinki, Finland; the Department of Obstetrics and Gynecology, Foothills Hospital, University of Calgary, Calgary, Alberta, Canada; Bayer Pharma AG, MülleBerlin, Germany; Bayer HealthCare Pharmaceuticals, Montville, New Jersey; and the Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of two low-dose levonorgestrel intrauterine contraceptive systems. METHODS:Nulliparous and parous women aged 18-35 years with regular menstrual cycles (21-35 days) requesting contraception were randomized to 3 years of treatment with one of two levonorgestrel intrauterine contraceptive systems: 13.5 mg total content or 19.5 mg total content. The primary outcome was the pregnancy rate, calculated as the Pearl Index. RESULTS: Overall, 1,432 and 1,452 women in the 13.5 mg intrauterine contraceptive system and 19.5 mg intrauterine contraceptive system groups, respectively, had a placement attempted and were included in the full analysis set to evaluate efficacy and safety. Mean (standard deviation) age was 27.1 (4.8) years; 39.2% were nulliparous. Over the 3-year study period, 0.33 pregnancies per 100 women-years (95% confidence interval [CI] 0.16-0.60) were observed with the 13.5 mg intrauterine contraceptive system compared with 0.31 per 100 women-years (95% CI 0.15-0.57) with the 19.5 mg intrauterine contraceptive system. Kaplan-Meier estimates for that period were 0.009 and 0.010, respectively. At least partial expulsions occurred in 4.56% and 3.58% and discontinuation rates resulting from a reported adverse event occurred in 21.9% and 19.1%, respectively. Ten of the 20 pregnancies were ectopic. Serious adverse events included six cases of pelvic inflammatory disease and one partial uterine perforation. CONCLUSIONS: Both lower-dose levonorgestrel intrauterine contraceptive systems were highly effective for 3 years of use and generally well tolerated. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00528112. LEVEL OF EVIDENCE: : I.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of two low-dose levonorgestrel intrauterine contraceptive systems. METHODS: Nulliparous and parous women aged 18-35 years with regular menstrual cycles (21-35 days) requesting contraception were randomized to 3 years of treatment with one of two levonorgestrel intrauterine contraceptive systems: 13.5 mg total content or 19.5 mg total content. The primary outcome was the pregnancy rate, calculated as the Pearl Index. RESULTS: Overall, 1,432 and 1,452 women in the 13.5 mg intrauterine contraceptive system and 19.5 mg intrauterine contraceptive system groups, respectively, had a placement attempted and were included in the full analysis set to evaluate efficacy and safety. Mean (standard deviation) age was 27.1 (4.8) years; 39.2% were nulliparous. Over the 3-year study period, 0.33 pregnancies per 100 women-years (95% confidence interval [CI] 0.16-0.60) were observed with the 13.5 mg intrauterine contraceptive system compared with 0.31 per 100 women-years (95% CI 0.15-0.57) with the 19.5 mg intrauterine contraceptive system. Kaplan-Meier estimates for that period were 0.009 and 0.010, respectively. At least partial expulsions occurred in 4.56% and 3.58% and discontinuation rates resulting from a reported adverse event occurred in 21.9% and 19.1%, respectively. Ten of the 20 pregnancies were ectopic. Serious adverse events included six cases of pelvic inflammatory disease and one partial uterine perforation. CONCLUSIONS: Both lower-dose levonorgestrel intrauterine contraceptive systems were highly effective for 3 years of use and generally well tolerated. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00528112. LEVEL OF EVIDENCE: : I.
Authors: Sharonne N Hayes; Esther S H Kim; Jacqueline Saw; David Adlam; Cynthia Arslanian-Engoren; Katherine E Economy; Santhi K Ganesh; Rajiv Gulati; Mark E Lindsay; Jennifer H Mieres; Sahar Naderi; Svati Shah; David E Thaler; Marysia S Tweet; Malissa J Wood Journal: Circulation Date: 2018-02-22 Impact factor: 29.690
Authors: Laureen M Lopez; Alissa Bernholc; Mario Chen; Thomas W Grey; Conrad Otterness; Carolyn Westhoff; Alison Edelman; Frans M Helmerhorst Journal: Cochrane Database Syst Rev Date: 2016-08-18
Authors: Kristina Gemzell-Danielsson; Dan Apter; Brian Hauck; Thomas Schmelter; Sarah Rybowski; Kimberly Rosen; Anita Nelson Journal: PLoS One Date: 2015-09-17 Impact factor: 3.240