The Effect of Tracleer® on Male Fertility

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00082186
• Date of registration: 30/04/2004
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: The Effect of Tracleer® on Male Fertility
• Scientific 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
• Date of first enrolment: July 2003
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00082186
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Australia, Brazil, Czech Republic, Hungary, United States

Contacts

• Name: Frederic Bodin, M.D.
• Affiliation: Actelion

• Name: Andrea Lauer, Ph.D.
• Affiliation: Actelion Pharmaceuticals US, Inc.

• Name: Maurizio Rainisio, Ph.D.
• Affiliation: Actelion

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: bosentan

Primary Outcome(s)

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.]

Secondary Outcome(s)

Semen volume, sperm motility and sperm morphology change [Time Frame: From baseline to 3 & 6 months]

Secondary ID(s)

AC-052-402

Source(s) of Monetary Support

Please refer to primary and secondary sponsors