EUCTR2004-004391-36-HU
Active, not recruiting
Not Applicable
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
DrugsTracleer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.
- Sponsor
- Actelion Pharmaceuticals Ltd.
- Enrollment
- 23
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male patients age 18\-65 years,
- •2\. Bosentan\-naïve,
- •3\. WHO functional class III/IV, in need of TRACLEER,
- •4\. Patients with iPAH or PAH secondary to CHD,
- •5\. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •2\.Patients with PAH secondary to connective tissue vascular diseases or HIV,
- •3\.Patients who have undergone a vasectomy,
- •4\.Patients with a sperm concentration \< 20 x 10\[6]/mL at the first or second baseline visit,
- •5\.Patients with average baseline sperm motility \<20% or normal sperm morphology \<5%,
- •6\.Body weight \< 50 kg,
- •7\.Hypotension, defined as systolic blood pressure less than 85 mm Hg,
- •8\.AST and/or ALT plasma levels greater than 3 times ULN,
- •9\.Hypersensitivity to bosentan or any of the components of the formulation,
- •10\.Treatment with glyburide, calcineurin inhibitors (e.g., cyclosporine A, tacrolimus) or fluconazole at inclusion or planned during the study,
- •11\.Treatment with hormone suppressive agents, including androgens, estrogens, anabolic steroids or glucocorticoids within the past 6 months or planned during the study,
Outcomes
Primary Outcomes
Not specified
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