Clinical trial NCT00082186: The Effect of Tracleer® on Male Fertility
Official title: TRACLEER® (Bosentan) Pulmonary Arterial Hypertension 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension, Pulmonary
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2004-05-04
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.

Primary outcomes:
measure: 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%.
timeFrame: From baseline to end of study.
Secondary outcomes:
measure: Semen volume, sperm motility and sperm morphology change
timeFrame: From baseline to 3 & 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Actelion Pharmaceuticals US, Inc.
name: Andrea Lauer, Ph.D.
role: STUDY_DIRECTOR
affiliation: Actelion
name: Maurizio Rainisio, Ph.D.
role: STUDY_DIRECTOR
affiliation: Actelion
name: Frederic Bodin, M.D.
role: STUDY_DIRECTOR
References: