Evidence map›Paper›PMID 28911934›Full record

Trial reportFertility and sterility2017

Evaluation of the efficacy and safety of dienogest in the treatment of painful symptoms in patients with adenomyosis: a randomized, double-blind, multicenter, placebo-controlled study.

Yutaka Osuga, Haruka Fujimoto-Okabe, Atsushi Hagino

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Fertility and sterility, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 4 pooled it
7.6field-weighted citation impact, top 3% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 4 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Clinical practice guidelines for endometriosis in Japan (The 3rd edition).The journal of obstetrics and gynaecology research · 2022
    Guideline
  4. Pooled it
  5. Observational
  6. Review
  7. Article
  8. Hormonal Treatment of Endometriosis: A Narrative Review.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  9. Article
  10. Review
  11. Observational
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Yutaka OsugaDepartment of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan. Electronic address: yutakaos-tky@umin.ac.jp.
Haruka Fujimoto-OkabeClinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.
Atsushi HaginoClinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.
Mochida Pharmaceutical (Japan) · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of dienogest (DNG), a progestational 19-norsteroid, in patients with symptomatic adenomyosis.

designPhase III, randomized, double-blind, multicenter, placebo-controlled study.

settingClinical study sites in Japan. PATIENT(S): Sixty-seven patients with adenomyosis. INTERVENTION(S): Patients were randomly assigned to receive DNG (2 mg/d, orally) or placebo for 16 weeks. In cases of complicated anemia, patients were treated for anemia before randomization. MAIN OUTCOME MEASURE(S): The primary end point was the change from baseline to after treatment pain score, using zero- to three-point verbal rating scales that defined pain severity according to limited ability to work and need for analgesics. The visual analogue scale was used as another pain parameter. RESULT(S): Decreases from baseline in the pain score and the visual analogue scale at the end of treatment were significantly more in the DNG group than in the placebo group (P<.001). During the treatment period, almost all of the patients treated with DNG experienced irregular uterine bleeding and one patient had mild anemia. No severe cases of anemia were observed. CONCLUSION(S): These results suggest that DNG is effective and well tolerated in the treatment for painful symptoms associated with adenomyosis not complicated by severe uterine enlargement or severe anemia. CLINICAL TRIAL REGISTRATION NUMBER: JapicCTI-142642(en).

Indexed as

AdenomyosisAdultDouble-Blind MethodFemaleHumansJapanMenstruation DisturbancesMiddle AgedNandrolonePain MeasurementPelvic PainPlacebosSeverity of Illness IndexTreatment OutcomeYoung AdultdienogestNandrolonePlacebosadenomyosisDienogestdouble-blindplacebo-controlled studyrandomized study

Identifiers

PMID28911934
OpenAlexW2752545486

What OpenQuestion holds

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Registered trials

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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.