Literature DB >> 19264712

A call for more transparency of registered clinical trials on endometriosis.

Sun-Wei Guo1, Lone Hummelshoj, David L Olive, Serdar E Bulun, Thomas M D'Hooghe, Johannes L H Evers.   

Abstract

In response to the pressing need for more efficacious and safer therapeutics for endometriosis, there have been numerous reports in the last decade of positive results from animal and in vitro studies of various compounds as potential therapeutics for endometriosis. A handful of these have undergone phase II/III clinical trials. Since the announcement of the International Committee of Medical Journal Editors that mandated registration as a prerequisite for publication, 57 endometriosis-related clinical trials have been registered at ClinicalTrials.gov, an Internet-based public depository for information on drug studies. Among them, 25 are listed as completed, and 2 as suspended. There are 15 completed phase II/III trials, which evaluated the efficacy of various promising compounds. Yet only three of the 15 trials (20%) have published their results. The remaining 12 (80%) studies so far have not published their findings. We argue that this apparent lack of transparency will actually not benefit the trial sponsors or the public, and will ultimately prove detrimental to research efforts attempting to develop more efficacious and safer therapeutics for endometriosis. Thus we call for more transparency of clinical trials on endometriosis.

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Year:  2009        PMID: 19264712      PMCID: PMC4102915          DOI: 10.1093/humrep/dep045

Source DB:  PubMed          Journal:  Hum Reprod        ISSN: 0268-1161            Impact factor:   6.918


  36 in total

Review 1.  Emerging drugs for endometriosis.

Authors:  Sun-Wei Guo
Journal:  Expert Opin Emerg Drugs       Date:  2008-12       Impact factor: 4.191

Review 2.  Recurrence of endometriosis and its control.

Authors:  Sun-Wei Guo
Journal:  Hum Reprod Update       Date:  2009-03-11       Impact factor: 15.610

Review 3.  Medical management of endometriosis and infertility.

Authors:  B A Lessey
Journal:  Fertil Steril       Date:  2000-06       Impact factor: 7.329

4.  Ability of recombinant human TNF binding protein-1 (r-hTBP-1) to inhibit the development of experimentally-induced endometriosis in rats.

Authors:  M D'Antonio; F Martelli; S Peano; R Papoian; F Borrelli
Journal:  J Reprod Immunol       Date:  2000 Oct-Nov       Impact factor: 4.054

Review 5.  Fulvestrant (AstraZeneca).

Authors:  Stephen R D Johnston
Journal:  Curr Opin Investig Drugs       Date:  2002-02

6.  Effects of anti-TNF-mAb treatment on pregnancy in baboons with induced endometriosis.

Authors:  Henrik Falconer; Jason M Mwenda; Daniel C Chai; Xioa-Yu R Song; Freddy J Cornillie; Agneta Bergqvist; Gabriel Fried; Thomas M D'Hooghe
Journal:  Fertil Steril       Date:  2007-09-04       Impact factor: 7.329

Review 7.  Dysmenorrhea: risk factors in women with endometriosis.

Authors:  Xishi Liu; Sun-Wei Guo
Journal:  Womens Health (Lond)       Date:  2008-07

8.  High prevalence of endometriosis in infertile women with normal ovulation and normospermic partners.

Authors:  Christel Meuleman; Birgit Vandenabeele; Steffen Fieuws; Carl Spiessens; Dirk Timmerman; Thomas D'Hooghe
Journal:  Fertil Steril       Date:  2008-08-05       Impact factor: 7.329

9.  Meta-analysis of rare events: an update and sensitivity analysis of cardiovascular events in randomized trials of rosiglitazone.

Authors:  Issa J Dahabreh; K Economopoulos
Journal:  Clin Trials       Date:  2008       Impact factor: 2.486

10.  Anti-TNF-alpha treatment for deep endometriosis-associated pain: a randomized placebo-controlled trial.

Authors:  P R Koninckx; M Craessaerts; D Timmerman; F Cornillie; S Kennedy
Journal:  Hum Reprod       Date:  2008-06-12       Impact factor: 6.918

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  7 in total

1.  Treatment with bazedoxifene, a selective estrogen receptor modulator, causes regression of endometriosis in a mouse model.

Authors:  Jaime Kulak; Catha Fischer; Barry Komm; Hugh S Taylor
Journal:  Endocrinology       Date:  2011-05-17       Impact factor: 4.736

2.  Legislation for trial registration and data transparency.

Authors:  Zhao-Xiang Bian; Tai-Xiang Wu
Journal:  Trials       Date:  2010-05-26       Impact factor: 2.279

Review 3.  Endometriosis: pathogenesis and treatment.

Authors:  Paolo Vercellini; Paola Viganò; Edgardo Somigliana; Luigi Fedele
Journal:  Nat Rev Endocrinol       Date:  2013-12-24       Impact factor: 43.330

4.  Practices and Attitudes Concerning Endometriosis Among Nurses Specializing in Gynecology.

Authors:  Anne Mette Bach; Mette Bech Risoer; Axel Forman; Lene Seibaek
Journal:  Glob Qual Nurs Res       Date:  2016-05-26

5.  Tetramethylpyrazine Retards the Progression and Fibrogenesis of Endometriosis.

Authors:  Shenghui Huang; Fengyi Xiao; Sun-Wei Guo; Tingting Zhang
Journal:  Reprod Sci       Date:  2022-01-31       Impact factor: 3.060

6.  Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform.

Authors:  S Kannan; S Gowri
Journal:  J Ayurveda Integr Med       Date:  2016-05-24

Review 7.  Endometriosis: current challenges in modeling a multifactorial disease of unknown etiology.

Authors:  Helena Malvezzi; Eliana Blini Marengo; Sérgio Podgaec; Carla de Azevedo Piccinato
Journal:  J Transl Med       Date:  2020-08-12       Impact factor: 5.531

  7 in total

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