The Effect of Tracleer® on Male Fertility

Hypertension, Pulmonary Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082186
• Other study ID #: AC-052-402
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2004
• Last updated: February 11, 2010
• Start date: July 2003
• Est. completion date: November 2007

Study information

• Verified date: February 2010
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• bosentan
Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital	Darlinghurst
Australia	Royal Perth Hospital	Perth
Brazil	Federal University of Sao Paulo	Sao Paulo
Brazil	University of Sao Paulo	Sao Paulo
Czech Republic	1st Internal Cardiology Clinic	Brno
Czech Republic	The Center for Congenital Heart Disease in Adults	Prague
Hungary	National Koranyi Institute of Pulmonology	Budapest
United States	University of Alabama-Birmingham	Birmingham	Alabama
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	University of California at San Diego	La Jolla	California
United States	New York Presbyterian Hospital	New York	New York
United States	Harbor - UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Czech Republic,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Semen volume, sperm motility and sperm morphology change		From baseline to 3 & 6 months	Yes

External Links

•   Tracleer approval page at Drugs@FDA.gov