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.
Conditions
Interventions
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: bosentan monohydrate
CAS Number: 147536-97-8
Current Sponsor code: Ro
Sponsors
Actelion Pharmaceuticals Ltd.
Eligibility
Sex/Gender
Male
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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%. | — |
Countries
Czech Republic, Hungary
Outcome results
None listed