| April 30, 2004 |
| July 9, 2008 |
| October 2002 |
| February 2007 (final data collection date for primary outcome 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%. [ Time Frame: From baseline to end of study. ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00082186 on ClinicalTrials.gov Archive Site |
| Semen volume, sperm motility and sperm morphology change [ Time Frame: From baseline to 3 & 6 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| The Effect of Tracleer® on Male Fertility |
| 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 |
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 IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Hypertension, Pulmonary |
| Drug: bosentan |
| Experimental: Oral bosentan tablets |
| |
| |
| Completed |
| 22 |
| November 2007 |
| February 2007 (final data collection date for primary outcome measure) |
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.
|
| Male |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Australia, Brazil, Czech Republic, Hungary |
| |
| NCT00082186 |
| Andrea Lauer, PhD, Actelion |
| AC-052-402 |
| Actelion |
|
| Study Director: |
Andrea Lauer, Ph.D. |
Actelion Pharmaceuticals US, Inc. |
|
| Study Director: |
Maurizio Rainisio, Ph.D. |
Actelion |
|
| Study Director: |
Frederic Bodin, M.D. |
Actelion |
|
|
| Actelion |
| July 2008 |
