Phase 4
N=24
Testosterone for Peripheral Vascular Disease
Hypogonadism · Peripheral Vascular Disease · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00504712 ↗Enrolled (actual)
24
Serious AEs
12.5%
Results posted
May 2022
Primary outcome: Primary: Change in Arterial Stiffness — 15.02; 15.08; 14.08; 16.12 index β
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Testosterone (Drug); saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Barnsley Hospital
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Arterial Stiffness |
15.02; 15.08; 14.08; 16.12; 14.01; 12.58 | — |
| SECONDARY Change in IMT |
0.856; 0.885; 0.843; 0.887; 0.841; 0.872 | — |
Summary
There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus.
- Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.
- Peripheral vascular disease as defined by
- previous diagnosis by a specialist vascular surgeon OR
- ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene).
- Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.
- Ability to give written informed consent after verbal and written explanation in the English language.
- Ability to comply with all study requirements.
Exclusion Criteria
- Current or previous breast cancer.
- Current or previous prostate cancer.
- Raised prostate specific antigen (PSA) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion.
- Severe symptoms of benign prostatic hypertrophy ('prostatism')
- Treatment with testosterone in the 3 months prior to the trial.
- Investigational drug treatment in the 3 months prior to the trial.
Data sourced from ClinicalTrials.gov (NCT00504712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.