Cited by 381Endometriosis Research and TreatmentEctopic Pregnancy Diagnosis and ManagementMenstrual Health and Disorders

The DOI matches its Crossref record; 41 of the 42 references it cites were found in a registry or an index; 6 of the 50 sources its claims cite were checked for support.

Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial

Abstract

BACKGROUND: Dienogest is a selective progestin that has been investigated in a clinical trial programme for the treatment of endometriosis. The current non-inferiority trial compared the efficacy and safety of dienogest against leuprolide acetate (LA) for treating the pain associated with endometriosis. METHODS: Patients with confirmed endometriosis were randomized to treatment with dienogest (2 mg/day, orally) or LA (3.75 mg, depot i.m. injection, every 4 weeks) for 24 weeks. The primary efficacy variable was absolute change in pelvic pain from baseline to end of treatment, assessed by visual analogue scale (VAS). Safety variables included adverse event profile, laboratory parameters, bone mineral density (BMD), bone markers and bleeding patterns. RESULTS: A total of 252 women were randomized to treatment with dienogest (n = 124) or LA (n = 128); 87.9 and 93.8% of the respective groups completed the trial. Absolute reductions in VAS score from baseline to Week 24 were 47.5 mm with dienogest and 46.0 mm with LA, demonstrating the equivalence of dienogest relative to LA. Hypoestrogenic effects (e.g. hot flushes) were reported less frequently in the dienogest group. As expected, bleeding episodes were suppressed less with dienogest than with LA. Changes in mean lumbar BMD between screening and final visit were +0.25% with dienogest and -4.04% with LA subgroups (P = 0.0003). Markers of bone resorption increased with LA but not dienogest. CONCLUSIONS: Dienogest 2 mg/day orally demonstrated equivalent efficacy to depot LA at standard dose in relieving the pain associated with endometriosis, although offering advantages in safety and tolerability.

Overview

Integrity signals

Registry

Crossref · 10.1093/humrep/dep469

Cites

41 of 42 references verified0 citation errors · 1 not checkable

Statistics

Nothing to recompute.

Verification

Claims the paper makes

6 of 50 cited sources checked · 1 supported · 0 flagged · accuracy not yet measured

Show all 64 claims

  • It may state two separate claims as one. 36
  • Probably not a substantial claim. 19
49 of 49
  • The paper relies on this without support.

    The open-label design did not bias the assessment of pelvic pain by visual analogue scale.

    “The study was a 24-week, multicentre, randomized, open-label, parallel-group study of dienogest versus LA.”
    “The primary efficacy variable was the absolute change in endometriosis-associated pelvic pain from baseline to the end of treatment, assessed by a visual analogue scale (VAS; 0 mm ¼ absence of pain, 100 mm ¼ unbearable pain).”
  • The paper relies on this without support.

    The bone mineral density subgroup is representative of the overall study population.

    “BMD was assessed in a subgroup of 57 women (n ¼ 26, dienogest; n ¼ 31, LA)”
    “In women whose measurements were available at both screening and final visit, mean lumbar BMD increased by 0.0022 g/cm 2 in the dienogest subgroup (n ¼ 21) and decreased by 0.0415 g/cm 2 in the LA subgroup (n ¼ 29)”
  • The paper relies on this without support.

    The trial population is representative of women with endometriosis in general.

    “Women aged 18 -45 years were eligible for study enrolment if they experienced pain associated with histologically proven endometriosis in revised-American Fertility Society (r-AFS, 1985) stages I -IV.”
    “Dienogest 2 mg/day orally demonstrated equivalent efficacy to depot LA at standard dose in relieving the pain associated with endometriosis”
  • The paper relies on this without support.

    Pelvic pain is one of the most important symptoms of endometriosis.

    “as pelvic pain is one of the most important symptoms of endometriosis”
  • The paper relies on this without support.

    Weight gain is a characteristic of a number of other progestins used in endometriosis.

    “Weight gain, which is a characteristic of a number of other progestins used in endometriosis, was minimal in dienogesttreated women.”
  • The paper relies on this without support.

    Danazol is associated with adverse effects on lipid metabolism and androgenic adverse effects.

    “Danazol, although remaining a standard therapy for endometriosis in some countries, is associated with adverse effects on lipid metabolism and androgenic adverse effects.”
6 of 6

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

  • Dienogest acne percentage is misrounded

    Minor

    Table II reports five cases among 120 women as 4.1%. That fraction is approximately 4.17%, which rounds to 4.2% at the table's precision.

    Reported 4.1 · recomputed 4.166667

1 of 1

Cited works that were retracted

Works this paper cites that were later retracted, from the retraction notices publishers deposit. Major when the notice came out before this paper was published.

  • Cites a retracted work: 10.1002/14651858.cd000346

    Major

    The cited work was retracted on 1999-04-26 (notice 10.1002/14651858.cd000346.pub2), before this paper was published (2010-01-19). Its authors could have known.

    Cited work 10.1002/14651858.cd000346 · retracted 1999-04-26 · notice 10.1002/14651858.cd000346.pub2 · this paper published 2010-01-19

1 of 1

Citations

Cites

1 retracted

Flagged first, then by citations

Show all 38 references

Research works printed but not linked: 11

  1. 1986, 34, 253
  2. 2007, Cochrane database of systematic reviews (Online), 3, CD001019
  3. 2009, International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 107, S190
  4. 2007, JPN PHARMACOL THER, 35, 769
  5. Mounsey, 2006, American family physician, 74, 594
  6. 2000, Cochrane database of systematic reviews (Online), 2, CD000346
  7. 2008, 73, 222
  8. 2003, 46, S7
  9. 2008, Fertility and sterility, 90, S140
  10. 2009, Fertility and sterility, 92, S107
  11. Wells, 1993, The Journal of Rheumatology, 20, 557

Cited by

Sorted by citations

Items 101–115 of 115

Metadata

Authors
Strowitzki, T., Marr, J., Gerlinger, C., Faustmann, T., & Seitz, C.
Affiliations
  • Heidelberg University (DE)
  • Bayer (Germany) (DE)
Venue
Human Reproduction
Published
2010-01-19
Volume
25
Issue
3
Pages
633-641
ISSN
  • 0268-1161 (ISSN-L)
  • 1460-2350
OpenAlex
W2101417341
Cited by
381
References
38
Citations by year
2026: 15 · 2025: 17 · 2024: 23 · 2023: 26 · 2022: 13 · 2021: 27 · 2020: 19 · 2019: 16 · 2018: 29 · 2017: 31 · 2016: 17 · 2015: 42 · 2014: 26 · 2013: 24 · 2012: 22
FWCI
30.34
Type
journal article
Language
en
Open access
closed
Locations
  • Human Reproduction (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
  • Health Sciences › Medicine › Obstetrics and Gynecology › Ectopic Pregnancy Diagnosis and Management
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Menstrual Health and Disorders
Keywords
dienogest, leuprolide, endometriosis, pelvic pain, GnRH agonist, non-inferiority, bone mineral density, bone resorption markers, bleeding patterns, safety and tolerability
MeSH terms
Adult, Endometriosis, Female, Humans, Nandrolone, Progestins, Quality of Life, Bone Density, Leuprolide, Pelvic Pain

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