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The objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 4 weeks in the treatment of hypogonadal men with chronic obstructive pulmonary disease (COPD) that are on oral glucocorticoid therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fispemifene | Drug | once daily for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in morning total testosterone levels | from baseline to Week 4 (end of therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total testosterone levels | from baseline to Weeks 2 and 6 | |
| Change in free testosterone, calculated free testosterone, and DHT | from baseline to Weeks 2, 4, and 6 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janne Komi, MD, PhD | Hormos Medical | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11316667 | Background | Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med. 2001 Apr;163(5):1256-76. doi: 10.1164/ajrccm.163.5.2101039. No abstract available. | |
| 12010840 |
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| Change in SHBG, E2, LH, FSH, and testosterone/E2 ratio |
| from baseline to Weeks 2, 4, and 6 |
| Change in serum lipid levels | from screening to Week 4 |
| Background |
| Wouters EF, Creutzberg EC, Schols AM. Systemic effects in COPD. Chest. 2002 May;121(5 Suppl):127S-130S. doi: 10.1378/chest.121.5_suppl.127s. |
| 12853506 | Background | Debigare R, Marquis K, Cote CH, Tremblay RR, Michaud A, LeBlanc P, Maltais F. Catabolic/anabolic balance and muscle wasting in patients with COPD. Chest. 2003 Jul;124(1):83-9. doi: 10.1378/chest.124.1.83. |
| 16100014 | Background | Van Vliet M, Spruit MA, Verleden G, Kasran A, Van Herck E, Pitta F, Bouillon R, Decramer M. Hypogonadism, quadriceps weakness, and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Nov 1;172(9):1105-11. doi: 10.1164/rccm.200501-114OC. Epub 2005 Aug 11. |
| 9543268 | Background | Kamischke A, Kemper DE, Castel MA, Luthke M, Rolf C, Behre HM, Magnussen H, Nieschlag E. Testosterone levels in men with chronic obstructive pulmonary disease with or without glucocorticoid therapy. Eur Respir J. 1998 Jan;11(1):41-5. doi: 10.1183/09031936.98.11010041. |
| 15271690 | Background | Casaburi R, Bhasin S, Cosentino L, Porszasz J, Somfay A, Lewis MI, Fournier M, Storer TW. Effects of testosterone and resistance training in men with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Oct 15;170(8):870-8. doi: 10.1164/rccm.200305-617OC. Epub 2004 Jul 21. |
| 9674442 | Background | Ferreira IM, Verreschi IT, Nery LE, Goldstein RS, Zamel N, Brooks D, Jardim JR. The influence of 6 months of oral anabolic steroids on body mass and respiratory muscles in undernourished COPD patients. Chest. 1998 Jul;114(1):19-28. doi: 10.1378/chest.114.1.19. |
| 7551381 | Background | Schols AM, Soeters PB, Mostert R, Pluymers RJ, Wouters EF. Physiologic effects of nutritional support and anabolic steroids in patients with chronic obstructive pulmonary disease. A placebo-controlled randomized trial. Am J Respir Crit Care Med. 1995 Oct;152(4 Pt 1):1268-74. doi: 10.1164/ajrccm.152.4.7551381. |
| 12171812 | Background | Yeh SS, DeGuzman B, Kramer T; M012 Study Group. Reversal of COPD-associated weight loss using the anabolic agent oxandrolone. Chest. 2002 Aug;122(2):421-8. doi: 10.1378/chest.122.2.421. |
| 15338805 | Background | Svartberg J, Aasebo U, Hjalmarsen A, Sundsfjord J, Jorde R. Testosterone treatment improves body composition and sexual function in men with COPD, in a 6-month randomized controlled trial. Respir Med. 2004 Sep;98(9):906-13. doi: 10.1016/j.rmed.2004.02.015. |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C532124 | fispemifene |
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