The Effect of Tracleer® on Male Fertility

NCT ID: NCT00082186

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2007-11-30

Brief 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).

Conditions

Hypertension, Pulmonary

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Oral bosentan tablets

Group Type: EXPERIMENTAL

bosentan

Intervention Type: DRUG

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

Interventions

bosentan

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

Intervention Type: DRUG

Other Intervention Names

Tracleer (R)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Actelion

Principal Investigators

Andrea Lauer, Ph.D.

Role: STUDY_DIRECTOR

Actelion Pharmaceuticals US, Inc.

Maurizio Rainisio, Ph.D.

Role: STUDY_DIRECTOR

Actelion

Frederic Bodin, M.D.

Role: STUDY_DIRECTOR

Actelion

Related Links

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=TRACLEER

Tracleer approval page at Drugs@FDA.gov

Other Identifiers

AC-052-402

Identifier Type: -

Identifier Source: org_study_id