Testosterone for Peripheral Vascular Disease

NCT00504712 | Completed Phase 4 Results

• 1 other identifier: 300
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.

Conditions

Hypogonadism; Peripheral Vascular Disease; Type 2 Diabetes

Keywords

Testosterone; Hypogonadism; Diabetes; PVD; RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in IMT

  Baseline, 12 weeks, and 26 weeks

Study Arms (2)

Active

EXPERIMENTAL

Testosterone 200 mg intramuscular every 2 weeks

Drug: Testosterone

Placebo

PLACEBO COMPARATOR

Saline

Drug: saline

Interventions

Testosterone DRUG

Sustanon- 200mg- Intramuscular testosterone every 2 weeks

Active

saline DRUG

Saline injection every two weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barnsley Hospital: lead

Study Sites (1)

Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire, S75 2EP, United Kingdom

Location

MeSH Terms

Conditions

Hypogonadism; Peripheral Vascular Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Testosterone; Sodium Chloride

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

It was more difficult than anticipated to recruit patients to the trial and despite extension of the trial beyond expected completion date the target recruitment was not achieved.

Results Point of Contact

• Title: Professor TH Jones
• Organization: Barnsley Hospital NHS Foundation Trust

01226 431684

Study Officials

• Thomas H Jones

  Barnsley Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: February 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 8, 2022
• Results First Posted: May 18, 2022

Record last verified: 2022-03

Locations

GB (1)