The Effect of Tracleer® on Male Fertility

Actelion Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Hypertension, Pulmonary

Treatments

Drug: bosentan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00082186

AC-052-402

Details and patient eligibility

About

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).

Enrollment

22 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.