Angina PectorisPhase 4NCT00131183
Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina
A Phase 4 study testing Nebido in people with Angina Pectoris, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to address the following questions on the effects of testosterone therapy in men with coronary ischaemia: Does the anti-anginal effect persist long term? Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Nebido
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2005to May 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males over 20 years of age
- Stable, chronic angina pectoris for > 1 month
- ST- segment depression of > 1mm within 12 minutes of the Bruce protocol
- Willing and able to give informed consent and comply with the study protocol
- Serum testosterone (< 12nmol/L)
Who cannot join
- Use of androgen therapy or anabolic steroids within 6 months of entry into the study (i.e. screening visit/visit 1) or concurrent use of androgens including dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, cytochrome P450 inducing medicines (e.g. quinidine, ketoconazole, macrolides), corticotrophins (ACTH), oxyphenbutazone
- Contraindication to treatment with Nebido®.
- Organic hypothalamic-pituitary pathology
- Prostate specific antigen (PSA) >= 4ng/ml
- Severe symptomatic benign prostatic hyperplasia
- Patients actively or potentially trying to start a family or requiring fertility treatment
Show all 19Show fewer
- Suspicion of, current, or past history of breast or prostatic carcinoma
- Myocardial infarction (MI), coronary artery bypass graft surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in the last three months.
- Significant hepatic, respiratory, haematological or renal disease
- Haematocrit > 50% at entry to the study (i.e. screening visit/visit 1)
- History of significant arrhythmia, Wolff-Parkinson-White (WPW) syndrome, > 1st degree heart block, or cerebrovascular accident (CVA) within the last three months
- History of drug or alcohol abuse
- Receiving other trial drugs within 12 weeks
- Hypotension (systolic blood pressure [BP] < 100 mm Hg)
- Severe, malignant, complicated, renovascular, secondary, or uncontrolled hypertension (BP > 180/114)
- Hypercalcaemia
- Nephrotic range proteinuria
- Symptomatic obstructive sleep apnoea syndrome
- Electrocardiogram (ECG) abnormalities that preclude ST- segment analysis (eg left bundle branch block [LBBB], atrial fibrillation [AF])
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: The Effect of Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina
This study aims to address the following questions on the effects of testosterone therapy in men with coronary ischaemia:
- Does the anti-anginal effect persist long term? Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months. The investigators' earlier studies were limited to 3 months.
- Does testosterone therapy in men affect the levels of measurable atheroma? There is currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of atheroma, although there is abundant evidence in animals to suggest a potential improvement.
This study addresses the two issues and would be of one-year duration but would be the longest trial of testosterone therapy in men with cardiovascular disease. The primary endpoint is the change in time to ST- segment depression of > 1mm during exercise testing.
Read the detailed description
In the past 4 years the investigators' research group has completed 2 studies on the effect of testosterone therapy on exercise induced coronary ischaemia (clinically manifest as angina pectoris). We, the investigators at Sheffield Teaching Hospitals, have shown that testosterone replacement therapy improved exercise duration on the treadmill and prolonged time to ischaemia (ischaemic threshold). Moreover, we demonstrated a dose response relationship between the increase in exercise duration and the baseline testosterone level so that men with lower baseline testosterone level derived the greatest symptomatic benefit from replacement therapy. Importantly we have also demonstrated that the effects of testosterone are maintained in the presence of concomitant anti-anginal drug therapy and at physiological levels of testosterone therapy. (English et al. 2000; Malkin 2004)
Furthermore we have found the prevalence of men with coronary disease and low serum testosterone levels to be approximately 25%. This represents a large population of men with low testosterone levels that may benefit symptomatically from testosterone therapy. These men qualify for androgen replacement therapy per se simply to relieve hypogonadal symptoms and maintain bone mineral density and there are clinical guidelines recommending physiological testosterone replacement in this cohort. (Morales and Lunenfeld 2002) The safety issues relating to testosterone treatment which comprise a theoretical increased risk of prostate neoplasia and increased erythropoiesis are of limited relevance in this population because replacement therapy only returns the testosterone level to the physiological range. Indeed, there is no evidence that appropriate testosterone therapy increases the risk of prostate cancer. More importantly, prostate cancer can be identified early by screening for prostate specific antigen allowing careful surveillance during replacement therapy.
This study aims to address the following questions on the effects of testosterone therapy in men with coronary ischaemia:
- Does the anti-anginal effect persist long term? Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months. Our earlier studies were limited to 3 months.
- Does testosterone therapy in men affect the levels of measurable atheroma? There is currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of atheroma, although there is abundant evidence in animals to suggest a potential improvement.
This study addresses the two issues and would be of one-year duration but would be the longest trial of testosterone therapy in men with cardiovascular disease.
The primary endpoint is change in time to ST- segment depression of > 1mm during exercise testing.
- Conditions
- Angina Pectoris
- Being tested
- Nebido
- Keywords
- Angina Pectoris, Arteriosclerosis, Testosterone
- Medical subject headings
- Angina Pectoris, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebidoDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time to ST- segment depression of > 1mm during exercise testing
Secondary outcomes (7)
Change in carotid atheroma assessed by media:intimal thickness ratio of the carotid artery
Change in time to exercise induced chest pain as judged by a single observer
Change in frequency of attacks of angina as recorded in the patients' angina diary
Change in high sensitivity C reactive protein (hs-CRP)
Change in scores on the Seattle Angina Questionnaire (SAQ)
Change in scores of quality of life (Euroquol)
Change in scores of depression using the Beck Depression Inventory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies 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
- Double blind
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Kevin S Channer, MBChB (Hons), Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131183
- Sponsor's protocol ID
- STH13979
- Status last verified
- Sep 2006
- First submitted
- 15 Aug 2005
- Last updated
- 2 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina
- ClinicalTrials.gov ID
- NCT00131183
- Acronym / sponsor ID
- STH13979
- Conditions
- Angina Pectoris
- Keywords
- Angina Pectoris, Arteriosclerosis, Testosterone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Sep 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to address the following questions on the effects of testosterone therapy in men with coronary ischaemia:
- Does the anti-anginal effect persist long term? Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months. The investigators' earlier studies were limited to 3 months.
- Does testosterone therapy in men affect the levels of measurable atheroma? There is currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of atheroma, although there is abundant evidence in animals to suggest a potential improvement.
This study addresses the two issues and would be of one-year duration but would be the longest trial of testosterone therapy in men with cardiovascular disease. The primary endpoint is the change in time to ST- segment depression of > 1mm during exercise testing.
Detailed description
In the past 4 years the investigators' research group has completed 2 studies on the effect of testosterone therapy on exercise induced coronary ischaemia (clinically manifest as angina pectoris). We, the investigators at Sheffield Teaching Hospitals, have shown that testosterone replacement therapy improved exercise duration on the treadmill and prolonged time to ischaemia (ischaemic threshold). Moreover, we demonstrated a dose response relationship between the increase in exercise duration and the baseline testosterone level so that men with lower baseline testosterone level derived the greatest symptomatic benefit from replacement therapy. Importantly we have also demonstrated that the effects of testosterone are maintained in the presence of concomitant anti-anginal drug therapy and at physiological levels of testosterone therapy. (English et al. 2000; Malkin 2004)
Furthermore we have found the prevalence of men with coronary disease and low serum testosterone levels to be approximately 25%. This represents a large population of men with low testosterone levels that may benefit symptomatically from testosterone therapy. These men qualify for androgen replacement therapy per se simply to relieve hypogonadal symptoms and maintain bone mineral density and there are clinical guidelines recommending physiological testosterone replacement in this cohort. (Morales and Lunenfeld 2002) The safety issues relating to testosterone treatment which comprise a theoretical increased risk of prostate neoplasia and increased erythropoiesis are of limited relevance in this population because replacement therapy only returns the testosterone level to the physiological range. Indeed, there is no evidence that appropriate testosterone therapy increases the risk of prostate cancer. More importantly, prostate cancer can be identified early by screening for prostate specific antigen allowing careful surveillance during replacement therapy.
This study aims to address the following questions on the effects of testosterone therapy in men with coronary ischaemia:
- Does the anti-anginal effect persist long term? Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months. Our earlier studies were limited to 3 months.
- Does testosterone therapy in men affect the levels of measurable atheroma? There is currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of atheroma, although there is abundant evidence in animals to suggest a potential improvement.
This study addresses the two issues and would be of one-year duration but would be the longest trial of testosterone therapy in men with cardiovascular disease.
The primary endpoint is change in time to ST- segment depression of > 1mm during exercise testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males over 20 years of age
- Stable, chronic angina pectoris for > 1 month
- ST- segment depression of > 1mm within 12 minutes of the Bruce protocol
- Willing and able to give informed consent and comply with the study protocol
- Serum testosterone (< 12nmol/L)
Key exclusion criteria (19 listed)
- Use of androgen therapy or anabolic steroids within 6 months of entry into the study (i.e. screening visit/visit 1) or concurrent use of androgens including dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, cytochrome P450 inducing medicines (e.g. quinidine, ketoconazole, macrolides), corticotrophins (ACTH), oxyphenbutazone
- Contraindication to treatment with Nebido®.
- Organic hypothalamic-pituitary pathology
- Prostate specific antigen (PSA) >= 4ng/ml
- Severe symptomatic benign prostatic hyperplasia
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 |
|---|---|---|
| Nebido | Drug | – |
Primary outcome
Change in time to ST- segment depression of > 1mm during exercise testing
7 secondary outcomes
Change in carotid atheroma assessed by media:intimal thickness ratio of the carotid artery
Change in time to exercise induced chest pain as judged by a single observer
Change in frequency of attacks of angina as recorded in the patients' angina diary
Change in high sensitivity C reactive protein (hs-CRP)
Change in scores on the Seattle Angina Questionnaire (SAQ)
Change in scores of quality of life (Euroquol)
Change in scores of depression using the Beck Depression Inventory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
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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.
Kevin S Channer, MBChB (Hons) principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
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 Nebido in people with Angina Pectoris, run by Sheffield Teaching Hospitals NHS Foundation Trust 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 5 inclusion and 19 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 2 Oct 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 time to ST- segment depression of > 1mm during exercise testing. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2019.