Status:
COMPLETED
The Effect of Tracleer® on Male Fertility
Lead Sponsor:
Actelion
Conditions:
Hypertension, Pulmonary
Eligibility:
MALE
18-65 years
Phase:
PHASE4
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00082186
Start Date
July 1 2003
End Date
November 1 2007
Last Update
February 3 2025
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