NCT00082186

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Actelion · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2003-07-01
• Primary completion: 2007-02-01
• Completion: 2007-11-01
• First posted: 2004-05-04
• Last updated: 2025-02-03