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Testosterone for Peripheral Vascular Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Barnsley Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Barnsley Hospital
ClinicalTrials.gov Identifier:
NCT00504712
First received: July 19, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men. Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.


Condition Intervention Phase
Hypogonadism
Peripheral Vascular Disease
Type 2 Diabetes
Drug: Testosterone
Drug: 0.9% saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Barnsley Hospital:

Primary Outcome Measures:
  • Change in arterial stiffness [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Change in IMT [ Time Frame: 3 months ]
  • Change in transcutaneous oxygen level [ Time Frame: 3 months ]
  • Change in ABPI [ Time Frame: 3 months ]
  • Change in Walking Impairment Questionnaire [ Time Frame: 3 months ]

Estimated Enrollment: 30
Study Start Date: February 2006
Estimated Study Completion Date: February 2008
Arms Assigned Interventions
Experimental: ACTIVE
Testosterone 200 mg intramuscular every 2 weeks
Drug: Testosterone
Sustanon- 200mg- Intramuscular testosterone every 2 weeks
Placebo Comparator: PLACEBO Drug: 0.9% saline
Saline injection every two weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes mellitus.
  2. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.
  3. 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).
  4. Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.
  5. Ability to give written informed consent after verbal and written explanation in the English language.
  6. Ability to comply with all study requirements.

Exclusion Criteria:

  1. Current or previous breast cancer.
  2. Current or previous prostate cancer.
  3. Raised prostate specific antigen (PSA) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion.
  4. Severe symptoms of benign prostatic hypertrophy (‘prostatism’)
  5. Treatment with testosterone in the 3 months prior to the trial.
  6. Investigational drug treatment in the 3 months prior to the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504712

Contacts
Contact: Roger D Stanworth 01226 777947 roger.stanworth@nhs.net

Locations
United Kingdom
Barnsley Hospital NHS Foundation Trust Recruiting
Barnsley, South Yorkshire, United Kingdom, S75 2EP
Contact: Roger D Stanworth    01226 777947    roger.stanworth@nhs.net   
Sponsors and Collaborators
Barnsley Hospital
Investigators
Principal Investigator: T Hugh Jones Barnsley Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00504712     History of Changes
Other Study ID Numbers: 300
Study First Received: July 19, 2007
Last Updated: July 19, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Barnsley Hospital:
Testosterone
Hypogonadism
Diabetes
PVD
RCT

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypogonadism
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Gonadal Disorders
Metabolic Diseases
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014