The Effect of Tracleer® on Male Fertility

NCT00082186 | Completed Phase 4

• 1 other identifier: AC-052-402
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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%.

  From baseline to end of study.

Secondary Outcomes (1)

• Semen volume, sperm motility and sperm morphology change

  From baseline to 3 & 6 months

Study Arms (1)

1

EXPERIMENTAL

Oral bosentan tablets

Drug: bosentan

Interventions

bosentan DRUG

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

Also known as: Tracleer (R)

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 hormone suppressive agents, including androgens, estrogens, anabolic steroids or glucocorticoids within the past 6 months or planned during the study.
• 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.

Sponsors & Collaborators

• Actelion: lead

Related Links

• Tracleer approval page at Drugs@FDA.gov

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andrea Lauer, Ph.D.

  Actelion Pharmaceuticals US, Inc.

  STUDY DIRECTOR

• Maurizio Rainisio, Ph.D.

  Actelion

  STUDY DIRECTOR

• Frederic Bodin, M.D.

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 30, 2004
• First Posted: May 4, 2004
• Study Start: July 1, 2003
• Primary Completion: February 1, 2007
• Study Completion: November 1, 2007
• Last Updated: February 3, 2025

Record last verified: 2025-01