HypogonadismPhase 2/3NCT02803073
Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction
A Phase 2/3 study testing Testosterone and Normal Saline in people with Hypogonadism and Acute Myocardial Infarction: Rehabilitation Phase, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of testosterone replacement in hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism, Acute Myocardial Infarction: Rehabilitation Phase
- What is being tested?
- Testosterone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to May 2017
- Phase
- Phase 2/3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All men status-post Myocardial Infarction or Non-ST Elevation-Acute Coronary Syndrome within the last 3-8 weeks enrolling in the cardiac rehabilitation program at Mission Fitness-Medical Center Hospital.
- Baseline free testosterone levels less than age-specific normal values.
- Males 18 years and older
Who cannot join
- Prostate Specific Antigen greater than age based, ethnic-specific cut points (see Appendix), history of metastatic prostate cancer or symptoms suggestive of severe Benign Prostatic Enlargement.
- Current use of testosterone, clomiphene or over the counter testosterone boosters
- Patients initiating cardiac rehabilitation 8+ weeks after MI or Non-ST Elevation-Acute Coronary Syndrome
- Congestive heart failure, New York Heart Association class IV
- Life expectancy less than 1 year,
- Baseline hematocrit of >50%
Show all 13Show fewer
- Allergic reactions to testosterone or testosterone vehicle (i.e. cotton seed oil, etc.)
- Physical inability to participate in rehabilitation program (examples: severe claudication, massive obesity, etc.)
- Participation in any other concurrent clinical trial, use of an investigational agent or therapeutic regimen within 30 days of study
- Patients formerly diagnosed with obstructive sleep apnea.
- Patients using opiate analgesics
- Patients with aspartate aminotransferase/alanine aminotransferase values more than 3 times normal
- History of Deep venous thrombosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Mission Fitness-Medical Center Hospital
Odessa, Texas, 79765
About this study
Official title: Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After A Recent Myocardial Infarction.
The purpose of this study is to determine the effects of testosterone replacement in hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial infarction.
Read the detailed description
Testosterone deficiency can decrease muscle strength. The researchers will replace testosterone in hypogonadal men undergoing rehabilitation exercises after heart attack.
- Being tested
- Testosterone, Normal Saline
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called testosterone cypionate
Testosterone Cypionate Intramuscular injections will be administered weekly
Normal SalineDrug
Also called Saline
Normal Saline Intramuscular injections will be administered weekly
| Study group | Role | What they receive |
|---|---|---|
| Testosterone Replacement | Experimental | The experimental group will receive 0.5 ml (100 mg) testosterone cypionate Intramuscular injections each week for 11 weeks. Receives: Drug: Testosterone |
| Control | Placebo comparator | Patients in the control group will receive intramuscular normal saline injections. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Equivalent
Measured: 12 weeks
Secondary outcomes (1)
6 minute walk test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017
- Study completionMay 2017
Why it stopped: Subjects could not be recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama Mukarram, MD, Principal investigator, Texas Tech University Health Sciences CenterCraig W Spellman, DO, Principal investigator, Texas Tech University Health Sciences CenterSandeep Dhindsa, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803073
- Sponsor's protocol ID
- L16-116
- Status last verified
- Nov 2019
- First submitted
- 8 Jun 2016
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After A Recent Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT02803073
- Acronym / sponsor ID
- L16-116
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subjects could not be recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Jun 2016 (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.
The purpose of this study is to determine the effects of testosterone replacement in hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial infarction.
Detailed description
Testosterone deficiency can decrease muscle strength. The researchers will replace testosterone in hypogonadal men undergoing rehabilitation exercises after heart attack.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone Replacement | Experimental | Drug: TestosteroneThe experimental group will receive 0.5 ml (100 mg) testosterone cypionate Intramuscular injections each week for 11 weeks. |
| Control | Placebo comparator | Drug: Normal SalinePatients in the control group will receive intramuscular normal saline injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All men status-post Myocardial Infarction or Non-ST Elevation-Acute Coronary Syndrome within the last 3-8 weeks enrolling in the cardiac rehabilitation program at Mission Fitness-Medical Center Hospital.
- Baseline free testosterone levels less than age-specific normal values.
- Males 18 years and older
Key exclusion criteria (13 listed)
- Prostate Specific Antigen greater than age based, ethnic-specific cut points (see Appendix), history of metastatic prostate cancer or symptoms suggestive of severe Benign Prostatic Enlargement.
- Current use of testosterone, clomiphene or over the counter testosterone boosters
- Patients initiating cardiac rehabilitation 8+ weeks after MI or Non-ST Elevation-Acute Coronary Syndrome
- Congestive heart failure, New York Heart Association class IV
- Life expectancy less than 1 year,
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 |
|---|---|---|
| TestosteroneAlso: testosterone cypionateTestosterone Cypionate Intramuscular injections will be administered weekly | Drug | Testosterone Replacement |
| Normal SalineAlso: SalineNormal Saline Intramuscular injections will be administered weekly | Drug | Control |
Primary outcome
Metabolic Equivalent
Time frame: 12 weeks
1 secondary outcome
6 minute walk test
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Hypogonadism
RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
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.
Osama Mukarram, MD principal investigator
Texas Tech University Health Sciences Center
Craig W Spellman, DO principal investigator
Texas Tech University Health Sciences Center
Sandeep Dhindsa, MD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Testosterone and Normal Saline in people with Hypogonadism and Acute Myocardial Infarction: Rehabilitation Phase, run by Texas Tech University Health Sciences Center at 1 site in United States.
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 3 inclusion and 13 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: withdrawn, as of the sponsor's last update on 21 Nov 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 States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Metabolic Equivalent (time frame: 12 weeks). 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 21 Nov 2019.