The Effect of Tracleer® on Male Fertility
- Registration Number
- NCT00082186
- Lead Sponsor
- Actelion
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 22
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 bosentan Oral bosentan tablets
- Primary Outcome Measures
Name Time Method 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%. From baseline to end of study.
- Secondary Outcome Measures
Name Time Method Semen volume, sperm motility and sperm morphology change From baseline to 3 & 6 months
Trial Locations
- Locations (13)
St. Vincent's Hospital
🇦🇺Darlinghurst, Australia
Harbor - UCLA Medical Center
🇺🇸Torrance, California, United States
University of California at San Diego
🇺🇸La Jolla, California, United States
Federal University of Sao Paulo
🇧🇷Sao Paulo, Brazil
The Center for Congenital Heart Disease in Adults
🇨🇿Prague, Czech Republic
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
University of Sao Paulo
🇧🇷Sao Paulo, Brazil
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
1st Internal Cardiology Clinic
🇨🇿Brno, Czech Republic
National Koranyi Institute of Pulmonology
🇭🇺Budapest, Hungary
Royal Perth Hospital
🇦🇺Perth, Australia