Trial reportObstetrics and gynecology2019
Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52-mg Intrauterine System.
Trial report in Obstetrics and gynecology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00995150 (A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Discontinuation rates of intrauterine contraception due to unfavourable bleeding: a systematic review.BMC women's health · 2022Pooled it
- Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial.Contraception · 2019Trial
- The effect of levonorgestrel-releasing intrauterine devices on acne vulgaris: A prospective cohort study.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Article
- Uterine Serous Carcinoma Following the Insertion of Levonorgestrel Intrauterine System: A Case Report and Literature Review.International journal of women's health · 2025Article
- Five-year Contraceptive Use of 52-mg Levonorgestrel Releasing Intrauterine System in Young Women, Menstrual Patterns, and New Contraceptive Choice.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2023Article
- Utility of the Levonorgestrel-Releasing Intrauterine System in the Treatment of Abnormal Uterine Bleeding and Dysmenorrhea: A Narrative Review.Journal of clinical medicine · 2022Article
- Hormonal Contraceptives and Dermatology.American journal of clinical dermatology · 2021Review
- Levonorgestrel-Releasing Intrauterine System as a Contraceptive Method in Nulliparous Women: A Systematic Review.Journal of clinical medicine · 2020Review
- Influence of Contraception Class on Incidence and Severity of Acne Vulgaris.Obstetrics and gynecology · 2020Article
- Consecutive Use of the 52 mg Levonorgestrel-releasing Intrauterine System: Variations in Bleeding Patterns.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2020Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
objectiveTo assess the 5-year contraceptive efficacy and safety of a levonorgestrel (LNG) 52-mg intrauterine system (IUS) from an ongoing 10-year phase 3 contraceptive trial.
methodsStudy investigators enrolled 1,751 nulliparous and parous females aged 16-45 years and desiring contraception to receive a novel LNG 52-mg IUS at 29 centers in the United States, including reproductive health clinics, private offices, and university centers. Participants had scheduled follow-up visits four times during the first year. After year 1, study visits occurred every 6 months, with phone contact at the 3-month point between visits. We assessed the primary outcome of pregnancy rate (Pearl Index) in females aged 16-35 years at enrollment through 60 months. The safety evaluation included all females for their entire duration of participation.
resultsThe 1,751 enrollees included 1,600 females aged 16-35 years and 151 aged 36-45 years. Successful IUS placement occurred in 1,714 (97.9%) participants. At the time of the data evaluation, 495 participants finished 5 years and 176 had entered the seventh year of IUS use. Nine pregnancies occurred, six of which were ectopic. The Pearl Indices for years 1 and 5 were 0.15 (95% CI 0.02-0.55) and 0.20 (95% CI 0.01-1.13) pregnancies per 100 women-years, respectively. The cumulative life-table pregnancy rate was 0.92% (0.46-1.82%) through 5 years. Participants aged 16-35 years at enrollment were significantly more likely to report new or worsening acne, dyspareunia, pelvic pain, and dysmenorrhea; participants aged 36-45 years at enrollment were more likely to report new or worsening weight increase. Discontinuation for adverse events occurred in 322 (18.8%) participants, most commonly related to expulsion (n=65 [3.8%]). Only 39 (2.2%) IUS users discontinued as a result of bleeding symptoms. Pelvic infection was diagnosed in 14 (0.8%) participants.
conclusionThis LNG 52-mg IUS is highly effective and safe over 5 years of use in U.S. females. CLINICAL
trial registrationClinicaltrials.gov, NCT00995150. FUNDING SOURCE: Medicines360.
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