The Effect of Tracleer® on Male Fertility
Information source: Actelion
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension, Pulmonary
Intervention: Tracleer® (bosentan) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Actelion Official(s) and/or principal investigator(s):
Andrea Lauer, Ph.D., Study Director, Affiliation: Actelion Pharmaceuticals US, Inc.
Maurizio Rainisio, Ph.D., Study Director, Affiliation: Actelion
Frederic Bodin, M.D., Study Director, Affiliation: Actelion
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).
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
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.
Locations and Contacts
Royal Perth Hospital, Perth 6000, Australia
St. Vincent's Hospital, Darlinghurst 2010, Australia
University of Sao Paulo, Sao Paulo, Brazil
Federal University of Sao Paulo, Sao Paulo, Brazil
1st Internal Cardiology Clinic, Brno, Czech Republic
The Center for Congenital Heart Disease in Adults, Prague, Czech Republic
National Koranyi Institute of Pulmonology, Budapest 1529, Hungary
University of Alabama-Birmingham, Birmingham, Alabama 35294, United States
University of California at San Diego, La Jolla, California 92037-1300, United States
Harbor - UCLA Medical Center, Torrance, California 90502, United States
University of Colorado Health Sciences Center, Denver, Colorado 80262, United States
New York Presbyterian Hospital, New York, New York 10032-3784, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Additional Information
Tracleer approval page at Drugs@FDA.gov
Starting date: October 2002
Last updated: March 10, 2008
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