The effects of testosterone therapy in men with pulmonary hypertensio
- Conditions
- Pulmonary Hypertension
- Registration Number
- EUCTR2004-003844-24-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 40
Male over 18, on regular mediciation, unlikely to change
Clinical pulmonary hypertension diagnosed 3 months and clinically stable
Pulmonary hypertension diagnosed on echocardiography: peak systolic pulmonary artery pressure>50mmg, mean >30mmHg
NYHA class II or III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Unable to perform shuttle test walk or comply with medication
Malignancy e.g. breast and prostate
Nehrotic syndrome
History of primary liver tumours
Hypercalcaemia and hypercalciuria
Hormone manipulating therapy
PSA above th enormal range
NYHA class IV
Current participation in other research projects
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect on functional capacity, as defined by an incease in shuttle walk distance, of testosterone supplementation as add on therapy in men with pulmonary hypertension;Secondary Objective: To evaluate the effect on cardiorespiratory, endoparacrine and quality of life parameters of testosterone supplementation as add on therapy in men with pulmonary hypertension;Primary end point(s): Change in functional capacity, as defined by an incease in shuttle walk distance,
- Secondary Outcome Measures
Name Time Method