The Effect of Tracleer® on Male Fertility - Full Text View

Sponsored by:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00082186

Purpose

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).

Condition	Intervention	Phase
Hypertension, Pulmonary	Drug: bosentan	Phase IV

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Bosentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by Actelion:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Semen volume, sperm motility and sperm morphology change [ Time Frame: From baseline to 3 & 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	22
Study Start Date:	October 2002
Study Completion Date:	November 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Oral bosentan tablets	Drug: bosentan Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082186

Locations

United States, Alabama
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California at San Diego
La Jolla, California, United States, 92037-1300
Harbor - UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10032-3784
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Australia
Royal Perth Hospital
Perth, Australia, 6000
St. Vincent's Hospital
Darlinghurst, Australia, 2010
Brazil
University of Sao Paulo
Sao Paulo, Brazil
Federal University of Sao Paulo
Sao Paulo, Brazil
Czech Republic
1st Internal Cardiology Clinic
Brno, Czech Republic
The Center for Congenital Heart Disease in Adults
Prague, Czech Republic
Hungary
National Koranyi Institute of Pulmonology
Budapest, Hungary, 1529

Sponsors and Collaborators

Actelion

Investigators

Study Director:	Andrea Lauer, Ph.D.	Actelion Pharmaceuticals US, Inc.
Study Director:	Maurizio Rainisio, Ph.D.	Actelion
Study Director:	Frederic Bodin, M.D.	Actelion

More Information

Tracleer approval page at Drugs@FDA.gov This link exits the ClinicalTrials.gov site

Responsible Party:	Actelion ( Andrea Lauer, PhD )
Study ID Numbers:	AC-052-402
Study First Received:	April 30, 2004
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00082186
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Infertility
Respiratory Tract Diseases
Hypertension, Pulmonary

Lung Diseases
Vascular Diseases
Bosentan
Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009