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:

April 30, 2004
May 4, 2004
February 12, 2010
July 2003
February 2007   (Final data collection date for primary outcome measure)
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. ]
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Complete list of historical versions of study NCT00082186 on Archive Site
Semen volume, sperm motility and sperm morphology change [ Time Frame: From baseline to 3 & 6 months ]
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The Effect of Tracleer® on Male Fertility
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
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).
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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension, Pulmonary
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)
Experimental: 1
Oral bosentan tablets
Intervention: Drug: bosentan
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2007
February 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Czech Republic,   Hungary,   United States
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Andrea Lauer, PhD, Actelion
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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
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP