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The Effect of Tracleer® on Male Fertility

NCT00082186 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-02-03

No results posted yet for this study

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

DRUG

bosentan

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

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Andrea Lauer, Ph.D. · Actelion Pharmaceuticals US, Inc.

  • Maurizio Rainisio, Ph.D. · Actelion

  • Frederic Bodin, M.D. · Actelion

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2007-02-28
Completion
2007-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00082186 on ClinicalTrials.gov