ArticleThe European journal of contraception & reproductive health care : the official journal of the European Society of Contraception2011
Effective treatment of heavy and/or prolonged menstrual bleeding without organic cause: pooled analysis of two multinational, randomised, double-blind, placebo-controlled trials of oestradiol valerate and dienogest.
Article in The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers.
What it found
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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 Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding.
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding.
Who cites it
13 citing papers in PubMed.
- Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial.Obstetrics and gynecology · 2018Trial
- A detailed review of pharmacokinetics/pharmacodynamics of progestogens in oral contraception.Frontiers in endocrinology · 2026Review
- Hormonal contraceptive use and anaemia: a nation-wide pharmacoepidemiological study from Northern Europe.European journal of epidemiology · 2025Article
- Historical Perspectives and Evolution of Menstrual Terminology.Frontiers in reproductive health · 2022Review
- Contraception During Perimenopause: Practical Guidance.International journal of women's health · 2022Review
- Heavy menstrual bleeding diagnosis and medical management.Contraception and reproductive medicine · 2017Review
- Knowledge of Latin American Obstetricians and Gynecologists regarding Heavy Menstrual Bleeding.Obstetrics and gynecology international · 2016Article
- Continuation rates, bleeding profile acceptability, and satisfaction of women using an oral contraceptive pill containing estradiol valerate and dienogest versus a progestogen-only pill after switching from an ethinylestradiol-containing pill in a real-life setting: results of the CONTENT study.International journal of women's health · 2016Article
- Recent advances in managing and understanding menstrual disorders.F1000prime reports · 2015Review
- Noncontraceptive benefits of the estradiol valerate/dienogest combined oral contraceptive: a review of the literature.International journal of women's health · 2014Review
- Novel oral contraceptive for heavy menstrual bleeding: estradiol valerate and dienogest.International journal of women's health · 2013Article
- Iatrogenic unscheduled (breakthrough) endometrial bleeding.Reviews in endocrine & metabolic disorders · 2012Review
- An overview of the development of combined oral contraceptives containing estradiol: focus on estradiol valerate/dienogest.Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo evaluate the efficacy of oestradiol valerate/dienogest (E2V/DNG) for the treatment of heavy and/or prolonged menstrual bleeding without organic pathology based on the analysis of data from two identically designed double-blind, randomised studies.
methodsWomen aged ≥ 18 years with heavy and/or prolonged menstrual bleeding were randomised to E2V/DNG (n = 269) or placebo (n = 152) for 196 days. Objective changes in menstrual blood loss (MBL) volume were assessed using the alkaline haematin method.
resultsAfter six months of treatment, median MBL decreased by 88% with E2V/DNG compared with 24% with placebo. The greatest reduction was achieved at the first withdrawal bleed after treatment initiation and it was sustained with no loss of effect throughout treatment.
conclusionE2V/DNG was more effective than placebo in reducing MBL in women with heavy and/or prolonged menstrual bleeding without organic pathology. The reduction was largely achieved as early as the first withdrawal bleed, with further gradual improvement throughout treatment.
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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.