The Effect of Tracleer® on Male Fertility | NCT00082186

Studies
The Effect of Tracleer® on Male Fertility

NCT00082186

Sponsor

Actelion

Status

Completed

Last Update Posted

Feb 3, 2025Actual

Enrollment

22Actual

Phase

Phase 4

Conditions

Hypertension, Pulmonary

Interventions

bosentan

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Feb 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Apr 30, 2004

First Submission Date that Met QC Criteria

May 3, 2004

First Posted Date

May 4, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2025

Last Update Posted Date

Feb 3, 2025Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Label	Type	Description	Intervention Names
1	Experimental	Oral bosentan tablets	Drug: bosentan

Name	Type	Description	Arm Group Labels	Other Names
bosentan	Drug	Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Semen volume, sperm motility and sperm morphology change		From baseline to 3 & 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Andrea Lauer, Ph.D.	Actelion Pharmaceuticals US, Inc.	Study Director
Maurizio Rainisio, Ph.D.	Actelion	Study Director
Frederic Bodin, M.D.	Actelion	Study Director

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals