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HypogonadismPhase 2NCT01061970

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

A Phase 2 study testing Fispemifene in people with Hypogonadism and Chronic Obstructive Pulmonary Disease, run by QuatRx Pharmaceuticals Company.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older, men only
What is being tested?
Fispemifene
How many people
15 participants
Where
No sites listed yet
Study dates
Jan 2007to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Subject has used any other injectable hormonal therapy (e.g. luteinizing hormone releasing hormone (LHRH)-antagonist or- agonist, growth hormone (GH) therapy) within 30 days prior to screening blood draw.
  • Subject has used any other medication affecting the Hypothalamic-Pituitary-Gonadal (HPG)-axis within 30 days prior to screening blood draw.
  • Subject has used any dietary supplements and/or herbal therapies affecting estrogen and/or testosterone metabolism or the HPG axis within 30 days prior to screening blood draw.
  • Subject is using potent inhibitors of CYP3A4 (e.g. ketoconazole, ritonavir, etc) on Day 1 or intends to use these medications during the study.
  • Subject is using potent inducers of CYP3A4 on Randomization Day 1or intends to use these medications during the study.
  • Subject is using medication metabolized by CYP2B6, CYP2C9, CYP2C19 and CYP3A4 and having a narrow therapeutic index on Day 1 or intends to use these medications during the study
  • Subject consumes more than 14 drinks containing alcohol per week. (One drink = 1.5 oz. of distilled spirits, or 12 oz. of beer, or 5 oz. of wine.).
  • Subject has a history of or current drug abuse within 6 months prior to screening visit.
  • Subject currently has untreated sleep apnea.
  • Subject has been a participant in another clinical intervention study within 30 days prior to the planned randomization on Day 1.
  • Subject has any physical or mental condition, which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
  • Subject has previously participated in this study or any other clinical study of fispemifene.

About this study

Official title: Efficacy and Safety of Fispemifene in the Treatment of Hypogonadal Men With Chronic Obstructive Pulmonary Disease That Are on Oral Glucocorticoid Therapy: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Study

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.

Being tested
Fispemifene
Keywords
Hypogonadism, Chronic Obstructive Pulmonary Disease, COPD
Medical subject headings
Hypogonadism, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FispemifeneDrug

    once daily for 4 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in morning total testosterone levels

    Measured: from baseline to Week 4 (end of therapy)

Secondary outcomes (4)

  1. Change in total testosterone levels

    Measured: from baseline to Weeks 2 and 6

  2. Change in free testosterone, calculated free testosterone, and DHT

    Measured: from baseline to Weeks 2, 4, and 6

  3. Change in SHBG, E2, LH, FSH, and testosterone/E2 ratio

    Measured: from baseline to Weeks 2, 4, and 6

  4. Change in serum lipid levels

    Measured: from screening to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2010 (estimated)
  2. Study startJan 2007
  3. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01061970
Sponsor's protocol ID
101-50605
Status last verified
Feb 2010
First submitted
2 Feb 2010
Last updated
3 Feb 2010
Results posted
No

Publications

  • 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.

    PubMed 11316667

  • 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.

    PubMed 12010840

  • 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.

    PubMed 12853506

  • 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.

    PubMed 16100014

  • 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.

    PubMed 9543268

  • 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.

    PubMed 15271690

  • 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.

    PubMed 9674442

  • 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.

    PubMed 7551381

  • 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.

    PubMed 12171812

  • 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.

    PubMed 15338805

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fispemifene in people with Hypogonadism and Chronic Obstructive Pulmonary Disease, run by QuatRx Pharmaceuticals Company.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in morning total testosterone levels (time frame: from baseline to Week 4 (end of therapy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01061970, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2010.

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