The Effect of Tracleer® on Male Fertility

This study has been completed.
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00082186
First received: April 30, 2004
Last updated: February 11, 2010
Last verified: February 2010
  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 4

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

Resource links provided by NLM:


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: July 2003
Study Completion Date: November 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral bosentan tablets
Drug: bosentan
Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.
Other Name: Tracleer (R)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
St. Vincent's Hospital
Darlinghurst, Australia, 2010
Royal Perth Hospital
Perth, Australia, 6000
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

Additional Information:
No publications provided

Responsible Party: Andrea Lauer, PhD, Actelion
ClinicalTrials.gov Identifier: NCT00082186     History of Changes
Other Study ID Numbers: AC-052-402
Study First Received: April 30, 2004
Last Updated: February 11, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014