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The Effect of Tracleer® on Male Fertility

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension, Pulmonary

Intervention: bosentan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
Andrea Lauer, Ph.D., Study Director, Affiliation: Actelion Pharmaceuticals US, Inc.
Maurizio Rainisio, Ph.D., Study Director, Affiliation: Actelion
Frederic Bodin, M.D., Study Director, Affiliation: Actelion

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).

Clinical Details

Official 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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%.

Secondary outcome: Semen volume, sperm motility and sperm morphology change

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Male.

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.

Locations and Contacts

St. Vincent's Hospital, Darlinghurst 2010, Australia

Royal Perth Hospital, Perth 6000, Australia

Federal University of Sao Paulo, Sao Paulo, Brazil

University of Sao Paulo, Sao Paulo, Brazil

1st Internal Cardiology Clinic, Brno, Czech Republic

The Center for Congenital Heart Disease in Adults, Prague, Czech Republic

National Koranyi Institute of Pulmonology, Budapest 1529, Hungary

University of Alabama-Birmingham, Birmingham, Alabama 35294, United States

University of California at San Diego, La Jolla, California 92037-1300, United States

Harbor - UCLA Medical Center, Torrance, California 90502, United States

University of Colorado Health Sciences Center, Denver, Colorado 80262, United States

New York Presbyterian Hospital, New York, New York 10032-3784, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Additional Information

Tracleer approval page at Drugs@FDA.gov

Starting date: July 2003
Last updated: February 11, 2010

Page last updated: August 23, 2015

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