Efficacy and Safety of Fispemifene in the Treatment of Hypogonadal Men With Chronic Obstructive Pulmonary Disease That Are on Oral Glucocorticoid Therapy

NCT01061970 | Completed Phase 2

• 1 other identifier: 101-50605
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypogonadism; Chronic Obstructive Pulmonary Disease

Keywords

Hypogonadism; Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (1)

• Change in morning total testosterone levels

  from baseline to Week 4 (end of therapy)

Secondary Outcomes (4)

• 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

• 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

Interventions

Fispemifene DRUG

once daily for 4 weeks

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has signed a written informed consent to participate in the study and has agreed to follow dosing instructions and complete all required study visits.
• The subject has COPD as defined by post-bronchodilator FEV1/FVC \<0.7 as measured at screening.
• The subject is on a stable dose of oral glucocorticoids (dose has not changed in the past 3 months and is not anticipated to change during the subject's participation in the study)
• The subject is a male ≥20 years of age at the time of randomization.
• The subject has a screening total testosterone level and a confirmatory baseline total testosterone level ≤ 350 ng/dl. Testosterone levels should be determined from early morning (0700h to 0900h) specimens.
• The subject has a serum LH level of 1.7-15.0 IU/L and an FSH level of 1.5-15.0 IU/L at the screening visit.

You may not qualify if:

• Subject has elevated prolactin. (≥21.5 ng/mL or above upper limit of reference lab range)
• Subject has evidence of Benign Prostatic Hypertrophy (BPH) with obstructive symptoms as indicated by an International Prostate Symptom Score (IPSS) of ≥15.
• Subject has a history of or current breast cancer, prostate cancer, abnormal DRE (with suspicion of malignancy) or elevated PSA (\>4 ng/ml ) or any other malignancy. History of basal cell carcinoma is allowed.
• Subject has a clinically significant endocrine or metabolic disease (e.g. thyroid disease, type I diabetes, severe hyperlipidemia). Severe hyperlipidemia is defined as total cholesterol \>300 mg/dL or triglycerides \>400 mg/dL. Type II diabetes is allowed only when HbAlc level is less than 8%.
• Subject has clinically significant cardiovascular disease, or abnormal findings on the baseline ECG, other than those related to COPD.
• Subject has systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥85 mmHg.
• Subject has significant polycythemia. (Hemoglobin \>17.5 gm/dL or above upper limit of reference lab range)
• Subject has current or history of severe renal or hepatic impairment.
• Subject has current or history of thromboembolic or blood coagulation disorder.
• Subject has current or history of cerebrovascular incident (e.g. bleeding, stroke or transient ischemic attack).
• Subject has clinically relevant abnormal findings in any safety laboratory tests including liver enzymes (ALT, AST) more than 1.5 times the upper limit of normal for the testing laboratory or creatinine \>1.4 mg/dl .
• Subject is heterozygous or homozygous for Factor V Leiden.
• Subject has clinically significant abnormal findings at physical examination other than those related to COPD.
• Subject has used transdermal testosterone therapy within 14 days or intramuscular testosterone therapy within 30 days prior to screening blood draw.
• Subject has used any form of hormone therapy affecting estrogen and/or androgen metabolism within 30 days prior to screening blood draw.

Sponsors & Collaborators

• QuatRx Pharmaceuticals Company: lead

Related Publications (10)

• 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.

  PMID: 11316667 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.

  PMID: 12010840 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.

  PMID: 12853506 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.

  PMID: 16100014 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.

  PMID: 9543268 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.

  PMID: 15271690 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.

  PMID: 9674442 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.

  PMID: 7551381 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.

  PMID: 12171812 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.

  PMID: 15338805 BACKGROUND

MeSH Terms

Conditions

Hypogonadism; Pulmonary Disease, Chronic Obstructive

Interventions

fispemifene

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janne Komi, MD, PhD

  Hormos Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: January 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 3, 2010

Record last verified: 2010-02