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 hypertensio
- 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.
- Registration Number
- EUCTR2004-004391-36-CZ
- Lead Sponsor
- Actelion Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 23
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
F.1.3.1 Number of subjects for this age range
1.Female,
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,
12.Current treatment less than 3 months prior to inclusion or planned new treatment with prostacylin or prostacyclin analogues (e.g., Flolan or Remodulin),
13.Patients receiving spironolactone (aldactone) less than 3 months prior to inclusion or dose >25 mg/day at baseline or anytime during the study,
14.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,
15.Known drug or alcohol dependence or any other factors that will interfere with conduct of the study,
16.Any illness other than PAH that will reduce life expectancy to less than 6 months,
17.Active cancer,
18.Prior treatment with an anti-neoplastic agent or ionizing radiation,
19.Hot tub/Jacuzzi use,
20.Uncontrolled diseases including diabetes, liver or kidney disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effects of chronic TRACLEER treatment on testicular function via semen analysis in male patients with idiopathic pulmonary arterial hypertension (iPAH) or PAH related to congenital heart disease (CHD);Secondary Objective: ;Primary end point(s): The primary endpoint of the study is the 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%.
- Secondary Outcome Measures
Name Time Method