Hypertension, PulmonaryPhase 4NCT00082186
The Effect of Tracleer® on Male Fertility
A Phase 4 study testing bosentan in people with Hypertension, Pulmonary, run by Actelion.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- bosentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Nov 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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
- Being tested
- bosentan
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bosentanDrug
Also called Tracleer (R)
Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral bosentan tablets Receives: Drug: bosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: From baseline to end of study.
Secondary outcomes (1)
Semen volume, sperm motility and sperm morphology change
Measured: From baseline to 3 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2004 (estimated)
- Study startJul 2003
- Primary completionFeb 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrea Lauer, Ph.D., Study director, Actelion Pharmaceuticals US, Inc.Maurizio Rainisio, Ph.D., Study director, ActelionFrederic Bodin, M.D., Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082186
- Sponsor's protocol ID
- AC-052-402
- Status last verified
- Jan 2025
- First submitted
- 30 Apr 2004
- Last updated
- 3 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00082186
- Acronym / sponsor ID
- AC-052-402
- Conditions
- Hypertension, Pulmonary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Feb 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 4 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bosentanOral bosentan tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bosentanAlso: Tracleer (R)Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks. | Drug | 1 |
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%.
Time frame: From baseline to end of study.
1 secondary outcome
Semen volume, sperm motility and sperm morphology change
Time frame: From baseline to 3 & 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Tracleer approval page at Drugs@FDA.govLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Lauer, Ph.D. study director
Actelion Pharmaceuticals US, Inc.
Maurizio Rainisio, Ph.D. study director
Actelion
Frederic Bodin, M.D. study director
Actelion
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bosentan in people with Hypertension, Pulmonary, run by Actelion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.