{
    "abstract": "To assess the bleeding profiles of the levonorgestrel 13.5\u00a0mg intrauterine device (LNG13.5-IUD) and Nova T copper 380\u00a0mm\nSingle-center, evaluator-masked, randomized study conducted in women aged 18-45 years starting these methods. Primary outcomes were number of bleeding days, self-reported bleeding intensity, Pictorial Blood Assessment Chart (PBAC) score, and blood biochemical values at baseline, months 3, 6, 12, 24, and 36 per 90-day reference periods except for PBAC (months). Secondary objectives were presence/duration/intensity of dysmenorrhea and tolerability.\nWe included 106 women aged 32.5\u00a0\u00b1\u00a06.7 years: 55 with LNG13.5-IUD and 51 with Cu380-IUD. Data for LNG13.5-IUD versus\u00a0Cu380-IUD at baseline and month 36 (both respectively) were as follows: (1) median (25th; 75th percentile) number of bleeding days: 12 (9.0;\u00a015.0) versus 12 (9.0;\u00a015.0), p\u00a0=\u00a00.82, and 4 (0; 13.7) versus\u00a015 (14.2;\u00a020.0), p\u00a0<\u00a00.001; (2) mean bleeding intensity: 1.7 for both, p\u00a0=\u00a00.66, and 0.7 and 2.2,\u00a0p\u00a0<\u00a00.001. Forty percent versus 0% presented with amenorrhea at month 36; (3) mean PBAC score (95% Confidence interval (CI): 50.7 (16.6;\u00a084.7) versus 130.4 (95.7;\u00a0165.0) at month 1, and 7.9 (-26.7;\u00a042.6) versus 126 (90.7; 161.2), p\u00a0<\u00a00.001; (4) median (25th; 75th percentile) ferritin levels (Ug/L) 33 (19;\u00a053) versus 30 (19;\u00a045), p\u00a0=\u00a00.70, and 59 (42;\u00a084) versus 21 (8;\u00a039). We did not observe changes or differences between groups in hemoglobin and hematocrit. The duration and intensity of dysmenorrhea were significantly lower with LNG13.5-IUD versus Cu380-IUD. Adverse events were those expected.\nLNG13.5-IUD is associated with a significant reduction in blood loss and dysmenorrhea compared with Cu380-IUD.\nWomen eligible for a levonorgestrel 13.5\u00a0mg intrauterine device (IUD) or a copper 380\u00a0mm",
    "authors": [
        {
            "affiliation": "Department of Obstetrics and Gynecology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Pediatrics, Obstetrics and Gynecology, and Preventive Medicine and Public Health Department, Universitat Aut\u00f2noma de Barcelona, Barcelona, Spain. Electronic address: jperello@santpau.cat.",
            "firstname": "Josep",
            "initials": "J",
            "lastname": "Perell\u00f3-Cap\u00f3"
        },
        {
            "affiliation": "Department of Obstetrics and Gynecology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Pediatrics, Obstetrics and Gynecology, and Preventive Medicine and Public Health Department, Universitat Aut\u00f2noma de Barcelona, Barcelona, Spain.",
            "firstname": "Josep",
            "initials": "J",
            "lastname": "Estadella-Tarriel"
        },
        {
            "affiliation": "Clinical Epidemiology and Public Health Service, IIB Sant Pau, Universitat Autonoma de Barcelona, Barcelona, Spain.",
            "firstname": "Ignasi",
            "initials": "I",
            "lastname": "Gich-Saladich"
        },
        {
            "affiliation": "Department of Obstetrics and Gynecology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.",
            "firstname": "Marta",
            "initials": "M",
            "lastname": "Bail\u00f3n-Queiruga"
        },
        {
            "affiliation": "Department of Obstetrics and Gynecology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Pediatrics, Obstetrics and Gynecology, and Preventive Medicine and Public Health Department, Universitat Aut\u00f2noma de Barcelona, Barcelona, Spain; Primary Care Interventions to Prevent Maternal and Child Chronic Diseases of Perinatal and Developmental Origin Network (RICORS), Instituto de Salud Carlos III, Madrid, Spain.",
            "firstname": "Elisa",
            "initials": "E",
            "lastname": "Llurba-Oliv\u00e9"
        },
        {
            "affiliation": "Department of Obstetrics and Gynecology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Pediatrics, Obstetrics and Gynecology, and Preventive Medicine and Public Health Department, Universitat Aut\u00f2noma de Barcelona, Barcelona, Spain.",
            "firstname": "Joaquim",
            "initials": "J",
            "lastname": "Calaf-Alsina"
        }
    ],
    "conclusions": null,
    "copyrights": "Copyright \u00a9 2023 Elsevier Inc. All rights reserved.",
    "doi": "10.1016/j.contraception.2023.110127",
    "journal": "Contraception",
    "keywords": [
        "Bleeding",
        "Contraception",
        "Copper intrauterine contraceptive device",
        "Hormonal contraception",
        "Hormone-releasing intrauterine contraceptive device",
        "Long-acting reversible contraception"
    ],
    "methods": null,
    "publication_date": "2023-07-25",
    "pubmed_id": "37487868",
    "results": "We included 106 women aged 32.5\u00a0\u00b1\u00a06.7 years: 55 with LNG13.5-IUD and 51 with Cu380-IUD. Data for LNG13.5-IUD versus\u00a0Cu380-IUD at baseline and month 36 (both respectively) were as follows: (1) median (25th; 75th percentile) number of bleeding days: 12 (9.0;\u00a015.0) versus 12 (9.0;\u00a015.0), p\u00a0=\u00a00.82, and 4 (0; 13.7) versus\u00a015 (14.2;\u00a020.0), p\u00a0<\u00a00.001; (2) mean bleeding intensity: 1.7 for both, p\u00a0=\u00a00.66, and 0.7 and 2.2,\u00a0p\u00a0<\u00a00.001. Forty percent versus 0% presented with amenorrhea at month 36; (3) mean PBAC score (95% Confidence interval (CI): 50.7 (16.6;\u00a084.7) versus 130.4 (95.7;\u00a0165.0) at month 1, and 7.9 (-26.7;\u00a042.6) versus 126 (90.7; 161.2), p\u00a0<\u00a00.001; (4) median (25th; 75th percentile) ferritin levels (Ug/L) 33 (19;\u00a053) versus 30 (19;\u00a045), p\u00a0=\u00a00.70, and 59 (42;\u00a084) versus 21 (8;\u00a039). We did not observe changes or differences between groups in hemoglobin and hematocrit. The duration and intensity of dysmenorrhea were significantly lower with LNG13.5-IUD versus Cu380-IUD. Adverse events were those expected.",
    "title": "Bleeding profile and safety of a levonorgestrel 13.5\u00a0mg intrauterine device versus Nova T copper 380\u00a0mm",
    "xml": "<Element 'PubmedArticle' at 0x788506265490>"
}