Evidence map›Paper›PMID 21681516›Full record

Trial reportArchives of gynecology and obstetrics2012

Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment.

Felice Petraglia, Daniela Hornung, Christian Seitz, Thomas Faustmann, Christoph Gerlinger, Stefano Luisi, Lucia Lazzeri, Thomas Strowitzki

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Archives of gynecology and obstetrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00225186 (A Multi-center, Open, One-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of T00660AA for the Treatment of Endometriosis Over 52 Weeks), which is not on this map. Cited by 42 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 7 pooled it
13.6field-weighted citation impact, top 1% 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.

NCT00225186 phase3completednot on this map

A Multi-center, Open, One-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of T00660AA for the Treatment of Endometriosis Over 52 Weeks (Follow-up to Study 307041)

TypeinterventionalSponsorBayerRan2004 to 2008Enrolled168ConditionsEndometriosisArmsVisanne (SH T00660AA , BAY86-5258)
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 7 syntheses or guidelines pooled it, 196 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Clinical practice guidelines for endometriosis in Japan (The 3rd edition).The journal of obstetrics and gynaecology research · 2022
    Guideline
  5. Pooled it
  6. Does dienogest influence the inflammatory response of endometriotic cells? A systematic review.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2016
    Pooled it
  7. Pooled it
  8. Trial
  9. Exploring New Treatment Strategies for Endometriosis-Narrative Review.International journal of molecular sciences · 2026
    Review
  10. Observational
  11. Article
  12. Review
  13. Observational
  14. Review
  15. Article
  16. Article
  17. Observational
  18. Article
  19. Dienogest in endometriosis treatment: A narrative literature review.Clinical and experimental reproductive medicine · 2023
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 3 countries.

Felice PetragliaDepartment of Pediatrics, Obstetrics and Reproductive Medicine, University of Siena, Viale R. Bracci N. 16, 53100, Siena, Italy. petraglia@unisi.it
Daniela Hornung
Christian Seitz
Thomas Faustmann
Christoph Gerlinger
Stefano Luisi
Lucia Lazzeri
Thomas Strowitzki
University of Siena · ITBayer (Germany) · DEBayer (United States) · USHeidelberg University · DESiemens Healthcare (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation.

methodsA multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment.

resultsThe completion rate among women who entered the open-label extension study was 90.5% (n = 152). A significant decrease in pelvic pain was shown during continued dienogest treatment (P < 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4%). No clinically relevant changes in laboratory parameters were observed. During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns.

conclusionsLong-term dienogest showed a favorable efficacy and safety profile, with progressive decreases in pain and bleeding irregularities during continued treatment; the decrease of pelvic pain persisted for at least 24 weeks after treatment cessation.

Indexed as

AdolescentAdultDrug Administration ScheduleEndometriosisFemaleFollow-Up StudiesGermanyHormone AntagonistsHumansItalyMiddle AgedNandrolonePelvic PainUkraineYoung AdultdienogestHormone AntagonistsNandrolone

Identifiers

PMID21681516
PMCPMC3249203
OpenAlexW2159474777

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.