The Effect of Tracleer® on Male Fertility

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Bosentan

Criteria

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.