COPDPhase 2/3NCT03674320
Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD
A Phase 2/3 study testing Testosterone Enanthate in people with COPD, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation of the airways and/or damage to the lungs which leads to progressive impairment in airflow and the ability to breathe. COPD affects 6 to 20% of the US population and is among the leading causes for mortality in men and women. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Testosterone Enanthate
- 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
- 1 Dec 2021to 1 Dec 2024
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40 - 80 years
- Stable weight (<10 lbs change in past 12 months - self reported)
- (Willing to) participate in pulmonary rehabilitation (PR) program at UTMB
- Air flow limitation based on spirometry (FEV1 < 60% predicted) (prior to PR)
- Daily symptoms according to COPD assessment test (CAT) > 15 (prior to PR)
Who cannot join
- Late stage COPD, GOLD Stage 3-4 (FEV1 > 60% predicted)
- Inability to perform 6-minute walking test or other physical therapy activities
- Inability/unwillingness to follow the pulmonary rehabilitation program
- Already more than 2 weeks into the pulmonary rehabilitation program at time of consenting
- Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes)
- Uncontrolled hypertension. Systolic blood pressure greater than or equal to 160mm Hg or a diastolic blood Pressure greater than or equal to 100mm Hg on three consecutive measurements taken at one-week intervals. Testosterone can cause fluid retention that could worsen uncontrolled hypertension. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria
Show all 9Show fewer
- History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months
- LDL cholesterol greater than 200 mg/dL as testosterone administration may elevate LDL cholesterol levels 9. Hematocrit greater than 51%
- 10. Current use of or history of recent anabolic steroid use (within 3 months) 11. Current abuse of alcohol or recreational drugs 12. Any other condition or event considered exclusionary by the PIs and covering faculty physician 13. Vulnerable populations including: individuals unable to consent on their own behalf, prisoners and pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation of the airways and/or damage to the lungs which leads to progressive impairment in airflow and the ability to breathe. COPD affects 6 to 20% of the US population and is among the leading causes for mortality in men and women. While COPD is principally a pathology of the airway, skeletal muscle wasting is a widely recognized comorbidity contributing to frequent and expensive hospital visits.
Hospital readmission rates among COPD patients are high and the majority of the readmissions are considered preventable. The reasons COPD patients lose muscle are still poorly understood although reduced pulmonary function has been associated with reduced testosterone levels. Muscle building treatments, including testosterone therapy, with and without exercise, have consistently been shown to promote improvements in body composition, exercise capacity, and health related quality of life of COPD patients.
The overall goal of this investigation is to provide an effective long-term treatment strategy that prevents the advancement of COPD in men and women through a safe, cycled administration of testosterone during the early stages of disease.
Read the detailed description
Male and female COPD patients participating in a 12 week pulmonary rehabilitation program at the University of Texas Medical Branch enrolled in the study will be randomized into either placebo or testosterone enanthate (100mg men, 25mg women) treatment. Testosterone and placebo will be given in a cyclic fashion during the pulmonary rehabilitation with single injections given on weeks 2, 3, 6, 7, 10 and 11. Baseline (during week 1 of rehabilitation) and post (during week 12 of rehabilitation) study testing will measure the effectiveness of testosterone on several measures listed in the outcome section.
- Conditions
- COPD
- Being tested
- Testosterone Enanthate, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone EnanthateDrug
Testosterone Enanthate (25 mg women, 100mg men) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11.
PlaceboDrug
Placebo Injection (saline) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (saline) injections will be given via intramuscular injection at study weeks 2,3, 6, 7, 10, and 11. Receives: Drug: Placebo |
| Testosterone Enanthate | Active comparator | Testosterone Enanthate (100mg men, 25mg women) will be given via intramuscular injection at study weeks 2, 3, 6, 7, 10 and 11. Receives: Drug: Testosterone Enanthate |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 day re-hospitalization rate
Re-hospitalization rates will be collected from the electronic medical record and/or subject interviews.
Measured: 90 days
Exercise Capacity as measured by distanced walked during 6 minute walk test at baseline study testing
Exercise capacity will be measured by distance walked in 6 minutes on a predefined course. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 6 minutes. Distance traveled for the 6 minutes will be recorded. The walking test will be completed at baseline. Data will be reported as meters (m) walked in 6 minutes.
Measured: baseline
Exercise Capacity as measured by distanced walked during 6 minute walk test at 12 weeks.
Exercise capacity will be measured by distance walked in 6 minutes on a predefined course. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 6 minutes. Distance traveled for the 6 minutes will be recorded. The walking test will be completed at baseline. Data will be reported as meters (m) walked in 6 minutes.
Measured: 12 weeks
Secondary outcomes (24)
Handgrip strength as measured by hand dyanometer at baseline study testing
Handgrip strength as measured by hand dyanometer at baseline of pulmonary rehabilatation and study drug intervention. Data will be reported as maximum force produced in kilograms.
Measured: baseline
Handgrip strength as measured by hand dyanometer at 12 weeks
Handgrip strength as measured by hand dyanometer after 12 weeks of pulmonary rehabilatation and study drug intervention. Data will be reported as maximum force produced in kilograms.
Measured: 12 weeks
Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at baseline
The BDS assesses difficulty breathing during the 6 minute walk test. Patients indicate their level of difficulty on a scale of 0 (no difficult) to 10 (maximal difficulty).
Measured: baseline
Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at 12 weeks
The BDS assesses difficulty breathing during the 6 minute walk test. Patients indicate their level of difficulty on a scale of 0 (no difficult) to 10 (maximal difficulty).
Measured: 12 weeks
Lung function as measured by Forced Expiratory Volume (FEV1) at baseline study testing
Lung function as measured by Forced Expiratory Volume (FEV1). FEV1 measured the amount of air that can be forcefully exhaled in one second. FEV1 is measured using a standard spirometer. Data will be reported as L of air expelled.
Measured: baseline
Lung function as measured by Forced Expiratory Volume (FEV1) at 12 weeks
Lung function as measured by Forced Expiratory Volume (FEV1). FEV1 measured the amount of air that can be forcefully exhaled in one second. FEV1 is measured using a standard spirometer. Data will be reported as L of air expelled.
Measured: 12 weeks
Lung Function as measured by Vital Capacity (VC) at baseline
Lung function as measured by Vital Capacity (VC) at baseline. VC measures the maximum amount of air that can be exhaled from the lung. VC is measured using a standard spirometer. Data will be reported as L of air expelled.
Measured: baseline
Lung Function as measured by Vital Capacity (VC) at 12 weeks
Lung function as measured by Vital Capacity (VC) at 12 weeks. VC measures the maximum amount of air that can be exhaled from the lung. VC is measured using a standard spirometer. Data will be reported as L of air expelled.
Measured: 12 weeks
Lung Function as measured by Forced Vital Capacity (FVC) at baseline
Lung function as measured by Forced Vital Capacity (FVC) at baseline. FVC measures the maximum amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is measured using a standard spirometer. Data will be reported as L of air expelled.
Measured: baseline
Lung Function as measured by Forced Vital Capacity (FVC) at 12 weeks.
Lung function as measured by Forced Vital Capacity (FVC) at baseline. FVC measures the maximum amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is measured using a standard spirometer. Data will be reported as L of air expelled.
Measured: 12 weeks
Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at baseline.
Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at baseline. FEF 25-75 measures the flow (speed) of air coming out of the lung during the middle portion of the forced expiration. FEF 25-75 is measured using a standard spirometer. Data will be reported as L/second.
Measured: baseline
Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at 12 weeks.
Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at 12 weeks. FEF 25-75 measures the flow (speed) of air coming out of the lung during the middle portion of the forced expiration. FEF 25-75 is measured using a standard spirometer. Data will be reported as L/second.
Measured: 12 weeks
Lung Function as measured by Maximal Voluntary Ventilation (MVV)at baseline.
Lung Function as measured by Maximal Voluntary Ventilation (MVV) at baseline. MVV measures the maximum volume of air that can be breathed in 15 seconds. MVV is measured using a standard spirometer. Data will be reported as L of air.
Measured: baseline
Lung Function as measured by Maximal Voluntary Ventilation (MVV)at 12 weeks.
Lung Function as measured by Maximal Voluntary Ventilation (MVV) at 12 weeks. MVV measures the maximum volume of air that can be breathed in 15 seconds. MVV is measured using a standard spirometer. Data will be reported as L of air.
Measured: 12 weeks
Fatigue as measured by Multidimensional Fatigue Symptom Inventory (MFSI) at baseline study testing.
Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue (range -24-96, with higher scores indicating more fatigue) and five subscales (general, physical, emotional, mental, vigor). With the exception of the vigor subscale, higher scores indicate greater fatigue.
Measured: baseline
Fatigue as measured by Multidimensional Fatigue Symptom Inventory (MFSI) at 12 weeks
Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue (range -24-96, with higher scores indicating more fatigue) and five subscales (general, physical, emotional, mental, vigor). With the exception of the vigor subscale, higher scores indicate greater fatigue.
Measured: 12 weeks
Quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) at baseline.
The St. George's Respiratory Questionnaire (SGRQ) measures the impact of the disease on overall health, daily life and perceived wellbeing in patients with obstructive airways disease. Scoring is calculated for three components (Symptoms, Activity and Impacts), these components are summed to create a total score. Total scores range from 0 to 100, with higher scores indicating more limitations.
Measured: baseline
Quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) at 12 weeks.
The St. George's Respiratory Questionnaire (SGRQ) measures the impact of the disease on overall health, daily life and perceived wellbeing in patients with obstructive airways disease. Scoring is calculated for three components (Symptoms, Activity and Impacts), these components are summed to create a total score. Total scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 12 weeks
Quality of Life as measured by COPD Assessment Test (CAT) at baseline study testing
The COPD Assessment Test (CAT) is an 8-item questionnaire measuring the impact of COPD on wellbeing and daily life. Each question is rated from 0 (lowest impact) to 5 (highest impact). Scores from each question are summed to calculate a total score. Total scores range from 0 to 40, with higher scores indicating higher impact from COPD. Classification of total score: 0-10 (low impact); 11-20 (medium impact); 21-30 (high impact); 31-40 (very high impact).
Measured: baseline
Quality of Life as measured by COPD Assessment Test (CAT) at 12 weeks
The COPD Assessment Test (CAT) is an 8-item questionnaire measuring the impact of COPD on wellbeing and daily life. Each question is rated from 0 (lowest impact) to 5 (highest impact). Scores from each question are summed to calculate a total score. Total scores range from 0 to 40, with higher scores indicating higher impact from COPD. Classification of total score: 0-10 (low impact); 11-20 (medium impact); 21-30 (high impact); 31-40 (very high impact).
Measured: 12 weeks
Quality of life as measured by Hospital Anxiety & Depression Scale (HADS) at baseline.
The Hospital Anxiety \& Depression Scale (HADS) is a 14-item questionnaire with 7 questions measuring anxiety and 7 questions measuring depression. Depression and anxiety will each have their own total score (0-21). Scores classifications: 0-7 (normal); 8-10 (mild); 11-14 (moderate); 15-21 (severe).
Measured: baseline
Quality of life as measured by Hospital Anxiety & Depression Scale (HADS) at 12 weeks.
The Hospital Anxiety \& Depression Scale (HADS) is a 14-item questionnaire with 7 questions measuring anxiety and 7 questions measuring depression. Depression and anxiety will each have their own total score (0-21). Scores classifications: 0-7 (normal); 8-10 (mild); 11-14 (moderate); 15-21 (severe).
Measured: 12 weeks
Total serum testosterone at baseline
Total serum testosterone will be measured at baseline by the UTMB Clinical Laboratory.
Measured: baseline
Total serum testosterone at 12 weeks
Total serum testosterone will be measured at baseline by the UTMB Clinical Laboratory.
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 posted17 Sep 2018
- Study start1 Dec 2021 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: No Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall J Urban, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674320
- Sponsor's protocol ID
- 18-0202
- Status last verified
- Jan 2021
- First submitted
- 13 Sep 2018
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD
- ClinicalTrials.gov ID
- NCT03674320
- Acronym / sponsor ID
- 18-0202
- Conditions
- COPD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 17 Sep 2018 (actual)
- 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.
Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation of the airways and/or damage to the lungs which leads to progressive impairment in airflow and the ability to breathe. COPD affects 6 to 20% of the US population and is among the leading causes for mortality in men and women. While COPD is principally a pathology of the airway, skeletal muscle wasting is a widely recognized comorbidity contributing to frequent and expensive hospital visits.
Hospital readmission rates among COPD patients are high and the majority of the readmissions are considered preventable. The reasons COPD patients lose muscle are still poorly understood although reduced pulmonary function has been associated with reduced testosterone levels. Muscle building treatments, including testosterone therapy, with and without exercise, have consistently been shown to promote improvements in body composition, exercise capacity, and health related quality of life of COPD patients.
The overall goal of this investigation is to provide an effective long-term treatment strategy that prevents the advancement of COPD in men and women through a safe, cycled administration of testosterone during the early stages of disease.
Detailed description
Male and female COPD patients participating in a 12 week pulmonary rehabilitation program at the University of Texas Medical Branch enrolled in the study will be randomized into either placebo or testosterone enanthate (100mg men, 25mg women) treatment. Testosterone and placebo will be given in a cyclic fashion during the pulmonary rehabilitation with single injections given on weeks 2, 3, 6, 7, 10 and 11. Baseline (during week 1 of rehabilitation) and post (during week 12 of rehabilitation) study testing will measure the effectiveness of testosterone on several measures listed in the outcome section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (saline) injections will be given via intramuscular injection at study weeks 2,3, 6, 7, 10, and 11. |
| Testosterone Enanthate | Active comparator | Drug: Testosterone EnanthateTestosterone Enanthate (100mg men, 25mg women) will be given via intramuscular injection at study weeks 2, 3, 6, 7, 10 and 11. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 40 - 80 years
- Stable weight (<10 lbs change in past 12 months - self reported)
- (Willing to) participate in pulmonary rehabilitation (PR) program at UTMB
- Air flow limitation based on spirometry (FEV1 < 60% predicted) (prior to PR)
- Daily symptoms according to COPD assessment test (CAT) > 15 (prior to PR)
Key exclusion criteria (9 listed)
- Late stage COPD, GOLD Stage 3-4 (FEV1 > 60% predicted)
- Inability to perform 6-minute walking test or other physical therapy activities
- Inability/unwillingness to follow the pulmonary rehabilitation program
- Already more than 2 weeks into the pulmonary rehabilitation program at time of consenting
- Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes)
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 |
|---|---|---|
| Testosterone EnanthateTestosterone Enanthate (25 mg women, 100mg men) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11. | Drug | Testosterone Enanthate |
| PlaceboPlacebo Injection (saline) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11. | Drug | Placebo |
Primary outcome
90 day re-hospitalization rate
Time frame: 90 days
Re-hospitalization rates will be collected from the electronic medical record and/or subject interviews.
Exercise Capacity as measured by distanced walked during 6 minute walk test at baseline study testing
Time frame: baseline
Exercise capacity will be measured by distance walked in 6 minutes on a predefined course. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 6 minutes. Distance traveled for the 6 minutes will be recorded. The walking test will be completed at baseline. Data will be reported as meters (m) walked in 6 minutes.
Exercise Capacity as measured by distanced walked during 6 minute walk test at 12 weeks.
Time frame: 12 weeks
Exercise capacity will be measured by distance walked in 6 minutes on a predefined course. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 6 minutes. Distance traveled for the 6 minutes will be recorded. The walking test will be completed at baseline. Data will be reported as meters (m) walked in 6 minutes.
24 secondary outcomes
Handgrip strength as measured by hand dyanometer at baseline study testing
Time frame: baseline
Handgrip strength as measured by hand dyanometer at 12 weeks
Time frame: 12 weeks
Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at baseline
Time frame: baseline
Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at 12 weeks
Time frame: 12 weeks
Lung function as measured by Forced Expiratory Volume (FEV1) at baseline study testing
Time frame: baseline
Lung function as measured by Forced Expiratory Volume (FEV1) at 12 weeks
Time frame: 12 weeks
Lung Function as measured by Vital Capacity (VC) at baseline
Time frame: baseline
Lung Function as measured by Vital Capacity (VC) at 12 weeks
Time frame: 12 weeks
Lung Function as measured by Forced Vital Capacity (FVC) at baseline
Time frame: baseline
Lung Function as measured by Forced Vital Capacity (FVC) at 12 weeks.
Time frame: 12 weeks
Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at baseline.
Time frame: baseline
Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at 12 weeks.
Time frame: 12 weeks
Lung Function as measured by Maximal Voluntary Ventilation (MVV)at baseline.
Time frame: baseline
Lung Function as measured by Maximal Voluntary Ventilation (MVV)at 12 weeks.
Time frame: 12 weeks
Fatigue as measured by Multidimensional Fatigue Symptom Inventory (MFSI) at baseline study testing.
Time frame: baseline
Fatigue as measured by Multidimensional Fatigue Symptom Inventory (MFSI) at 12 weeks
Time frame: 12 weeks
Quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) at baseline.
Time frame: baseline
Quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) at 12 weeks.
Time frame: 12 weeks
Quality of Life as measured by COPD Assessment Test (CAT) at baseline study testing
Time frame: baseline
Quality of Life as measured by COPD Assessment Test (CAT) at 12 weeks
Time frame: 12 weeks
Quality of life as measured by Hospital Anxiety & Depression Scale (HADS) at baseline.
Time frame: baseline
Quality of life as measured by Hospital Anxiety & Depression Scale (HADS) at 12 weeks.
Time frame: 12 weeks
Total serum testosterone at baseline
Time frame: baseline
Total serum testosterone at 12 weeks
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 2 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Randall J Urban, MD principal investigator
University of Texas
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 Enanthate in people with COPD, run by The University of Texas Medical Branch, Galveston 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 5 inclusion and 9 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 2 Feb 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 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?
90 day re-hospitalization rate (time frame: 90 days). The study lists 3 primary outcomes in all. 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 Feb 2022.