Trial reportThe European journal of contraception & reproductive health care : the official journal of the European Society of Contraception2014
Impact of a new levonorgestrel intrauterine system, Levosert(®), on heavy menstrual bleeding: results of a one-year randomised controlled trial.
Trial report in The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid: a systematic review and meta-analysis.BMC women's health · 2022Pooled it
- Progestogen-releasing intrauterine systems for heavy menstrual bleeding.The Cochrane database of systematic reviews · 2020Pooled it
- Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review.BMC women's health · 2020Pooled it
- Menstrual cup use and intrauterine device expulsion in a copper intrauterine device randomized trial.Contraception · 2024Trial
- Menstrual blood loss is an independent determinant of hemoglobin and ferritin levels in premenopausal blood donors.Acta obstetricia et gynecologica Scandinavica · 2024Article
- Levonorgestrel intrauterine device use and incident idiopathic intracranial hypertension among commercially insured women.Contraception · 2023Observational
- Variation of outcome reporting in studies of interventions for heavy menstrual bleeding: a systematic review.Facts, views & vision in ObGyn · 2022Article
- [Efficacy and adverse effects of levonorgestrel-releasing intrauterine system in treatment of adenomyosis].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2019Article
- New developments in intrauterine device use: focus on the US.Open access journal of contraception · 2016Review
- Recent advances in contraception.F1000prime reports · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate a new levonorgestrel-releasing intrauterine system (LNG-IUS) called Levosert(®) for the treatment of heavy menstrual bleeding (HMB) in comparison to the reference product Mirena(®).
methodsA multicentre, randomised, controlled trial, in non-menopausal women diagnosed with functional HMB (defined as menstrual blood loss [MBL] ≥ 80 mL) randomised to either Levosert(®) or Mirena(®) and followed for up to one year. MBL was evaluated using a validated modified version of the Wyatt pictogram.
resultsA total of 280 women were randomised (141 to Levosert(®) and 139 to Mirena(®)). During the one-year treatment period, both Levosert(®) and Mirena(®) dramatically decreased MBL and increased haemoglobin and ferritin levels. There were no statistically significant differences between Levosert(®) and Mirena(®) regarding any of the parameters evaluated during the study. Similar bleeding patterns were observed in both groups. Levosert(®) was inserted with the same ease as Mirena(®). Both treatments were associated with identical expulsion rates and no perforations occurred in either treatment group.
conclusionLevosert(®), a new LNG-IUS designed to release the same daily amount of LNG as Mirena(®), is highly effective in the treatment of HMB. No differences were observed between Levosert(®) and Mirena(®) regarding all evaluated outcomes, including safety profile.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.