| Trial ID: | L2560 |
| Source ID: | NCT00504712
|
| Associated Drug: |
Testosterone
|
| Title: |
Testosterone for Peripheral Vascular Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00504712/results
|
| Conditions: |
Hypogonadism|Peripheral Vascular Disease|Type 2 Diabetes
|
| Interventions: |
DRUG: Testosterone|DRUG: saline
|
| Outcome Measures: |
Primary: Change in Arterial Stiffness, The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist., Baseline, 12 weeks, and 26 weeks | Secondary: Change in IMT, Progression of Carotid intima-media thickness measured in mm, Baseline, 12 weeks, and 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: Barnsley Hospital
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-02
|
| Completion Date: |
2009-12
|
| Results First Posted: |
2022-05-18
|
| Last Update Posted: |
2022-06-08
|
| Locations: |
Barnsley Hospital NHS Foundation Trust, Barnsley, South Yorkshire, S75 2EP, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00504712
|
