An overview of the current status of clinical trials on endometriosis: Issues and concerns

Fertility and Sterility

Volumn 101, Issue 1, 2014, Pages 183-190.e4

  Guo, Sun Wei ^a  

^a FUDAN UNIVERSITY   (China)

Author keywords

Clinical trials; drug; endometriosis; issues; sponsorship; status

Indexed keywords

BIOLOGICAL PRODUCT; CHEMOKINE RECEPTOR CCR1 INHITIBITOR; DANAZOL; GESTAGEN; GONADORELIN; GONADORELIN ANTAGONIST; LEVONORGESTREL; NERVE GROWTH FACTOR ANTIBODY; ORAL CONTRACEPTIVE AGENT; PLACEBO; PRINABEREL; PROGESTERONE RECEPTOR MODULATOR; PROTEIN INHIBITOR; SELECTIVE ESTROGEN RECEPTOR MODULATOR; UNCLASSIFIED DRUG;

COST BENEFIT ANALYSIS; CROSS-SECTIONAL STUDY; DISEASE REGISTRY; DRUG INDUSTRY; ENDOMETRIOSIS; HUMAN; INTRAUTERINE CONTRACEPTIVE DEVICE; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; REVIEW; TREATMENT DURATION;

EID: 84891560091     PISSN: 00150282     EISSN: 15565653     Source Type: Journal    
DOI: 10.1016/j.fertnstert.2013.08.050     Document Type: Article

References (51)

1. S.W. Guo, L. Hummelshoj, D.L. Olive, S.E. Bulun, T.M. D'Hooghe, and J.L. Evers A call for more transparency of registered clinical trials on endometriosis Hum Reprod 24 2009 1247 1254
2. S.W. Guo, and J.H.L. Evers Lack of transparency of clinical trials on endometriosis Obstet Gynecol 121 2013 1281 1290
3. R. Inhaka, and R.R. Gentleman R: a language for data analysis and graphics J Comput Graph Statist 5 1996 1923 1927
4. F.T. Bourgeois, S. Murthy, and K.D. Mandl Outcome reporting among drug trials registered in ClinicalTrials.gov Ann Intern Med 153 2010 158 166
5. P. Stratton, N. Sinaii, J. Segars, D. Koziol, R. Wesley, and C. Zimmer et al. Return of chronic pelvic pain from endometriosis after raloxifene treatment: a randomized controlled trial Obstet Gynecol 111 2008 88 96
6. D. Roumiantseva, S. Carini, I. Sim, and T.H. Wagner Sponsorship and design characteristics of trials registered in ClinicalTrials.gov Contemp Clin Trials 34 2013 348 355
7. S.W. Guo, and D.L. Olive Two unsuccessful clinical trials on endometriosis and a few lessons learned Gynecol Obstet Invest 64 2007 24 35 (Pubitemid 47014376)
8. P. Vercellini, P. Crosignani, E. Somigliana, P. Vigano, M.P. Frattaruolo, and L. Fedele "Waiting for Godot": a commonsense approach to the medical treatment of endometriosis Hum Reprod 26 2011 3 13
9. M. Angell The truth about the drug companies: how they deceive us and what to do about it 2005 Random House Trade Paperbacks New York
10. D.N. Lathyris, N.A. Patsopoulos, G. Salanti, and J.P. Ioannidis Industry sponsorship and selection of comparators in randomized clinical trials Eur J Clin Invest 40 2010 172 182
11. D.J. Safer Design and reporting modifications in industry-sponsored comparative psychopharmacology trials J Nerv Ment Dis 190 2002 583 592
12. H. Melander, J. Ahlqvist-Rastad, G. Meijer, and B. Beermann Evidence b(i)ased medicine - selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications BMJ 326 2003 1171 1173 (Pubitemid 36649049)
13. L. Bero, F. Oostvogel, P. Bacchetti, and K. Lee Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others PLoS Med 4 2007 e184
14. G. Rattinger, and L. Bero Factors associated with results and conclusions of trials of thiazolidinediones PLoS One 4 2009 e5826
15. M. Sinyor, A. Schaffer, K.A. Smart, A.J. Levitt, K.L. Lanctot, and N.H. Grysman Sponsorship, antidepressant dose, and outcome in major depressive disorder: meta-analysis of randomized controlled trials J Clin Psychiatry 73 2012 e277 e287
16. K. Chwalisz, M.C. Perez, D. Demanno, C. Winkel, G. Schubert, and W. Elger Selective progesterone receptor modulator development and use in the treatment of leiomyomata and endometriosis Endocr Rev 26 2005 423 438 (Pubitemid 40686652)
17. D. DeManno, W. Elger, R. Garg, R. Lee, B. Schneider, and H. Hess-Stumpp et al. Asoprisnil (J867): a selective progesterone receptor modulator for gynecological therapy Steroids 68 2003 1019 1032 (Pubitemid 37532427)
18. H.A. Harris, K.L. Bruner-Tran, X. Zhang, K.G. Osteen, and C.R. Lyttle A selective estrogen receptor-beta agonist causes lesion regression in an experimentally induced model of endometriosis Hum Reprod 20 2005 936 941 (Pubitemid 40667838)
19. Z. Yao, X. Shen, I. Capodanno, M. Donnelly, J. Fenyk-Melody, and J. Hausamann et al. Validation of rat endometriosis model by using raloxifene as a positive control for the evaluation of novel SERM compounds J Invest Surg 18 2005 177 183 (Pubitemid 41200609)
20. N. Pullen, C.L. Birch, G.J. Douglas, Q. Hussain, I. Pruimboom-Brees, and R.J. Walley The translational challenge in the development of new and effective therapies for endometriosis: a review of confidence from published preclinical efficacy studies Hum Reprod Update 17 2011 791 802
21. S.W. Guo Methodological issues in preclinical mouse efficacy studies of adenomyosis Current Obstet Gynecol Rep 1 2012 138 145
22. S.R. Soares, A. Martinez-Varea, J.J. Hidalgo-Mora, and A. Pellicer Pharmacologic therapies in endometriosis: a systematic review Fertil Steril 98 2012 529 555
23. R.C. Jones The effect of a luteinizing hormone releasing hormone (LRH) agonist (Wy-40,972), levonorgestrel, danazol and ovariectomy on experimental endometriosis in the rat Acta Endocrinol (Copenh) 106 1984 282 288 (Pubitemid 14107051)
24. I. Henig, R.G. Rawlins, H.P. Weinrib, and W.P. Dmowski Effects of danazol, gonadotropin-releasing hormone agonist, and estrogen/progestogen combination on experimental endometriosis in the ovariectomized rat Fertil Steril 49 1988 349 355 (Pubitemid 18047835)
25. Y. Sakura, T. Masaki, K. Sudo, M. Nomura, and A. Shino Histological studies on the therapeutic effect of sustained-release microspheres of a potent LHRH agonist (leuprorelin acetate) in an experimental endometriosis model in rats Endocrinol Jpn 37 1990 719 729
26. M. Sakata, N. Terakawa, T. Mizutani, O. Tanizawa, K. Matsumoto, and N. Terada et al. Effects of danazol, gonadotropin-releasing hormone agonist, and a combination of danazol and gonadotropin-releasing hormone agonist on experimental endometriosis Am J Obstet Gynecol 163 1990 1679 1684
27. T. Mizutani, M. Sakata, and N. Terakawa Effect of gonadotropin-releasing hormone agonists, nafarelin, buserelin, and leuprolide, on experimentally induced endometriosis in the rat Int J Fertil Menopausal Stud 40 1995 106 111
28. F. Quereda, J. Barroso, and P. Acien Individual and combined effects of triptoreline and gestrinone on experimental endometriosis in rats Eur J Obstet Gynecol Reprod Biol 67 1996 35 40 (Pubitemid 26179495)
29. R.C. Jones The effect of a luteinizing hormone-releasing hormone antagonist on experimental endometriosis in the rat Acta Endocrinol (Copenh) 114 1987 379 382 (Pubitemid 17025802)
30. K.L. Sharpe, M.C. Bertero, and M.W. Vernon Rapid regression of endometriosis by a new gonadotropin-releasing hormone antagonist in rats with surgically induced disease Prog Clin Biol Res 323 1990 449 458
31. D. Altintas, A. Kokcu, M. Tosun, M.B. Cetinkaya, and B. Kandemir Comparison of the effects of cetrorelix, a GnRH antagonist, and leuprolide, a GnRH agonist, on experimental endometriosis J Obstet Gynaecol Res 34 2008 1014 1019
32. H.A. Harris, K.L. Bruner-Tran, X. Zhang, K.G. Osteen, and C.R. Lyttle A selective estrogen receptor-beta agonist causes lesion regression in an experimentally induced model of endometriosis Hum Reprod 20 2005 936 941 (Pubitemid 40667838)
33. Z. Yao, X. Shen, I. Capodanno, M. Donnelly, J. Fenyk-Melody, and J. Hausamann et al. Validation of rat endometriosis model by using raloxifene as a positive control for the evaluation of novel SERM compounds J Invest Surg 18 2005 177 183 (Pubitemid 41200609)
34. M. Kudoh, Y. Susaki, Y. Ideyama, T. Nanya, M. Mori, and H. Shikama Inhibitory effects of a novel aromatase inhibitor, YM511, on growth of endometrial explants and insulin-like growth factor-I gene expression in rats with experimental endometriosis J Steroid Biochem Mol Biol 63 1997 75 80 (Pubitemid 28018139)
35. S. Yano, Y. Ikegami, and K. Nakao Studies on the effect of the new non-steroidal aromatase inhibitor fadrozole hydrochloride in an endometriosis model in rats Arzneimittelforschung 46 1996 192 195 (Pubitemid 26078239)
36. G. Yildirim, R. Attar, F. Ozkan, B. Kumbak, C. Ficicioglu, and N. Yesildaglar The effects of letrozole and melatonin on surgically induced endometriosis in a rat model: a preliminary study Fertil Steril 93 2010 1787 1792
37. D.I. Lebovic, M. Kir, and C.L. Casey Peroxisome proliferator-activated receptor-gamma induces regression of endometrial explants in a rat model of endometriosis Fertil Steril 82 Suppl 3 2004 1008 1013 (Pubitemid 39341177)
38. Y. Katsuki, Y. Takano, Y. Futamura, Y. Shibutani, D. Aoki, and Y. Udagawa et al. Effects of dienogest, a synthetic steroid, on experimental endometriosis in rats Eur J Endocrinol 138 1998 216 226 (Pubitemid 28131102)
39. T. Singtripop, T. Mori, S. Sakamoto, S. Sassa, M.K. Park, and S. Kawashima Suppression of the development of uterine adenomyosis by danazol treatment in mice Life Sci 51 1992 1119 1125
40. A. Golan, R. Dargenio, and R.M. Winston The effect of treatment on experimentally produced endometrial peritoneal implants Fertil Steril 46 1986 954 958 (Pubitemid 17187676)
41. M. Igarashi A new therapy for pelvic endometriosis and uterine adenomyosis: local effect of vaginal and intrauterine danazol application Asia Oceania J Obstet Gynaecol 16 1990 1 12
42. M. Igarashi, Y. Abe, M. Fukuda, A. Ando, M. Miyasaka, and M. Yoshida et al. Novel conservative medical therapy for uterine adenomyosis with a danazol-loaded intrauterine device Fertil Steril 74 2000 412 413 (Pubitemid 30604216)
43. B.F. Barrier, G.W. Bates, M.M. Leland, D.A. Leach, R.D. Robinson, and A.M. Propst Efficacy of anti-tumor necrosis factor therapy in the treatment of spontaneous endometriosis in baboons Fertil Steril 81 Suppl 1 2004 775 779 (Pubitemid 38333059)
44. A. Steinleitner, H. Lambert, M. Suarez, N. Serpa, and S. Roy Immunomodulation in the treatment of endometriosis-associated subfertility: use of pentoxifylline to reverse the inhibition of fertilization by surgically induced endometriosis in a rodent model Fertil Steril 56 1991 975 979
45. W.B. Nothnick, T.E. Curry, and M.W. Vernon Immunomodulation of rat endometriotic implant growth and protein production Am J Reprod Immunol 31 1994 151 162 (Pubitemid 24149361)
46. S. Colette, S. Defrere, J.C. Lousse, A. Van Langendonckt, J.P. Gotteland, and E. Loumaye et al. Inhibition of steroid sulfatase decreases endometriosis in an in vivo murine model Hum Reprod 26 2011 1362 1370
47. M. Oktem, I. Esinler, D. Eroglu, N. Haberal, N. Bayraktar, and H.B. Zeyneloglu High-dose atorvastatin causes regression of endometriotic implants: a rat model Hum Reprod 22 2007 1474 1480 (Pubitemid 47062821)
48. Y. Sawatari, T. Horii, and H. Hoshiai Oily contrast medium as a therapeutic agent for infertility because of mild endometriosis Fertil Steril 59 1993 907 911 (Pubitemid 23104199)
49. G.A. Edelstam, A.C. Sjösten, and C.W. Salamon Pertubation with lignocaine - a possible new treatment for women with endometriosis and impaired fertility Ups J Med Sci 106 2001 51 57
50. E. Novella-Maestre, C. Carda, I. Noguera, A. Ruiz-Sauri, J.A. Garcia-Velasco, and C. Simon et al. Dopamine agonist administration causes a reduction in endometrial implants through modulation of angiogenesis in experimentally induced endometriosis Hum Reprod 24 2009 1025 1035
51. F. Delgado-Rosas, R. Gomez, H. Ferrero, F. Gaytan, J. Garcia-Velasco, and C. Simon et al. The effects of ergot and non-ergot-derived dopamine agonists in an experimental mouse model of endometriosis Reproduction 142 2011 745 755