HypogonadismPhase 4NCT00504712

Testosterone for Peripheral Vascular Disease

A Phase 4 study testing Testosterone and saline in people with Hypogonadism and Peripheral Vascular Disease, run by Barnsley Hospital at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hypogonadism, Peripheral Vascular Disease, Type 2 Diabetes
What is being tested?: Testosterone and saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited Kingdom
Study dates: Feb 2006to Dec 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, S75 2EP

Other trials in United Kingdom

About this study

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

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

Read the detailed description

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.

Conditions: Hypogonadism, Peripheral Vascular Disease, Type 2 Diabetes
Being tested: Testosterone, saline
Keywords: Testosterone, Hypogonadism, Diabetes, PVD, RCT
Medical subject headings: Hypogonadism, Peripheral Vascular Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TestosteroneDrug
Sustanon- 200mg- Intramuscular testosterone every 2 weeks
salineDrug
Saline injection every two weeks

Study groups in NCT00504712
Study group	Role	What they receive
Active	Experimental	Testosterone 200 mg intramuscular every 2 weeks Receives: Drug: Testosterone
Placebo	Placebo comparator	Saline Receives: Drug: saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 12 weeks, and 26 weeks

Secondary outcomes (1)

Change in IMT
Progression of Carotid intima-media thickness measured in mm
Measured: Baseline, 12 weeks, and 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Dec 2009

First posted20 Jul 2007 (estimated)
Study startFeb 2006
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypogonadismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00504712
Sponsor's protocol ID: 300
Status last verified: Mar 2022
First submitted: 19 Jul 2007
Last updated: 8 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00504712
Acronym / sponsor ID: 300
Conditions: Hypogonadism, Peripheral Vascular Disease, Type 2 Diabetes
Keywords: Testosterone, Hypogonadism, Diabetes, PVD, RCT
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Barnsley HospitalUniversity, hospital or other
Study start: Feb 2006
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 20 Jul 2007 (estimated)
Results: Posted 18 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active	Experimental	Drug: TestosteroneTestosterone 200 mg intramuscular every 2 weeks
Placebo	Placebo comparator	Drug: salineSaline

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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
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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TestosteroneSustanon- 200mg- Intramuscular testosterone every 2 weeks	Drug	Active
salineSaline injection every two weeks	Drug	Placebo

Primary outcome

Change in Arterial Stiffness
Time frame: Baseline, 12 weeks, and 26 weeks
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.

1 secondary outcome

Change in IMT
Time frame: Baseline, 12 weeks, and 26 weeks

Results and safety

Results posted to the registry on 18 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active	11	11
Placebo	13	13

Primary outcome: Change in Arterial Stiffness

Time frame: Baseline, 12 weeks, and 26 weeks. Mean (Standard Deviation). Unit: index β

Measure	Active n = 11	Placebo n = 13
Baseline	15.02 (5.74)	15.08 (6.59)
12 weeks	14.08 (5.36)	16.12 (7.42)
26 weeks	14.01 (4.53)	12.58 (5.55)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	1 of 11 (9.1%)	3 of 11 (27.3%)	Not reported
Placebo	2 of 13 (15.4%)	4 of 13 (30.8%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypogonadism

Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
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RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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RecruitingPhase 3
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
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RecruitingObservational study
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas H Jones principal investigator

Barnsley Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Testosterone and saline in people with Hypogonadism and Peripheral Vascular Disease, run by Barnsley Hospital at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Arterial Stiffness (time frame: Baseline, 12 weeks, and 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00504712.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.