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The Effect of Tracleer® on Male Fertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082186
Recruitment Status : Completed
First Posted : May 4, 2004
Last Update Posted : February 12, 2010
Information provided by:

Brief Summary:
The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on testicular function via semen analysis in male patients with primary pulmonary arterial hypertension (PAH).

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: bosentan Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TRACLEER® (Bosentan) Pulmonary Arterial Hypertension A Multicenter, Open-label, Single-arm Safety Study to Investigate the Effects of Chronic TRACLEER® Treatment on Testicular Function in Male Patients With Pulmonary Arterial Hypertension
Study Start Date : July 2003
Actual Primary Completion Date : February 2007
Actual Study Completion Date : November 2007

Arm Intervention/treatment
Experimental: 1
Oral bosentan tablets
Drug: bosentan
Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.
Other Name: Tracleer (R)

Primary Outcome Measures :
  1. Proportion of patients with a mean decrease in sperm concentration to 7.5 x 10[6]/mL or below, without a single sperm concentration ≥ 20 x 10[6]/mL, at 3 or 6 months. This proportion is considered of clinical relevance if greater than 30%. [ Time Frame: From baseline to end of study. ]

Secondary Outcome Measures :
  1. Semen volume, sperm motility and sperm morphology change [ Time Frame: From baseline to 3 & 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male patients age 18-65 years.
  • Bosentan-naïve.
  • PPH, WHO functional class III/IV, in need of TRACLEER
  • Patients pulmonary arterial hypertension (PAH) secondary to congenital heart disease.
  • Written informed consent.

Exclusion Criteria:

  • Female
  • Patients with PAH secondary to connective tissue vascular diseases or HIV.
  • Patients who have undergone a vasectomy.
  • Patients with an average baseline sperm concentration < 15 x 10[6]/mL, or any sample with a sperm concentration <= 7.5 x 10[6]/mL.
  • Patients with an average baseline sperm motility <20% or normal sperm morphology <5%.
  • Body weight < 50 kg.
  • Hypotension, defined as systolic blood pressure less than 85 mm Hg.
  • AST and/or ALT plasma levels greater than 3 times ULN.
  • Hypersensitivity to bosentan or any of the components of the formulation.
  • Treatment with glyburide, cyclosporine A or tacrolimus at inclusion or planned during the study.
  • Treatment with hormone suppressive agents, including androgens, estrogens, anabolic steroids or glucocorticoids within the past 6 months or planned during the study.
  • Current treatment less than 3 months prior to inclusion or planned treatment with prostacyclin or prostacyclin analogues (e.g., Flolanâ or Remodulin).
  • Patients who received an investigational drug in the month preceding the study start or who are due to be treated with another investigational drug during the study period.
  • Known drug or alcohol dependence or any other factors that will interfere with conduct of the study.
  • Any illness other than PPH that will reduce life expectancy to less than 6 months.
  • Active cancer.
  • Prior treatment with an anti-neoplastic agent or ionizing radiation.
  • Hot tub/Jacuzzi use.
  • Uncontrolled diseases including diabetes, liver or kidney disease.
  • Patients receiving spironolactone (aldactone) less than 3 months prior to inclusion or dose >25 mg/day at baseline or anytime during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00082186

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United States, Alabama
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California at San Diego
La Jolla, California, United States, 92037-1300
Harbor - UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10032-3784
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
St. Vincent's Hospital
Darlinghurst, Australia, 2010
Royal Perth Hospital
Perth, Australia, 6000
Federal University of Sao Paulo
Sao Paulo, Brazil
University of Sao Paulo
Sao Paulo, Brazil
Czech Republic
1st Internal Cardiology Clinic
Brno, Czech Republic
The Center for Congenital Heart Disease in Adults
Prague, Czech Republic
National Koranyi Institute of Pulmonology
Budapest, Hungary, 1529
Sponsors and Collaborators
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Study Director: Andrea Lauer, Ph.D. Actelion Pharmaceuticals US, Inc.
Study Director: Maurizio Rainisio, Ph.D. Actelion
Study Director: Frederic Bodin, M.D. Actelion
Additional Information:
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Responsible Party: Andrea Lauer, PhD, Actelion Identifier: NCT00082186    
Other Study ID Numbers: AC-052-402
First Posted: May 4, 2004    Key Record Dates
Last Update Posted: February 12, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action