HypogonadismPhase 1NCT01378299
CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy
A Phase 1 study testing Testosterone Cypionate in people with Hypogonadism, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Testosterone (T) replacement prevents bone loss and relieves symptoms associated with androgen deficiency in male patients with hypogonadism, but at the expense of an increase in prostate-related adverse events and in the hematocrit values above the normal which may lead to bad circulatory outcomes. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosterone Cypionate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2011to 7 Nov 2017
- Phase
- Phase 1
- 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 40 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male Veterans with low total testosterone (<300 ng/dl) as defined by the Endocrine Society, who are between 40-75 years of age.
- These patients must be ambulatory; and be willing and able to provide written informed consent.
Who cannot join
- history of prostate cancer, breast cancer
- history of testicular disease
- untreated sleep apnea
- any ongoing illness that, in the opinion of the investigator, could prevent the subject from completing the study
- patients with a hematocrit of more than 50% (2010 Endocrine Society Guidelines)
- prostate-related findings of a palpable prostate nodule on exam, a serum PSA of 4.0 ng/ml or more, International Prostate Symptom Score >8(9), urinary postvoid residual by ultrasound of >149 ml, or an abnormal transrectal ultrasound
Show all 23Show fewer
- patients who are on androgen replacement therapy, selective androgen receptor modulator, or finasteride
- patients currently on medications that affects bone metabolism such as:
- estrogen
- the selective estrogen receptor modulator (SERM) as raloxifene
- use of bisphosphonates (i.e. risedronate, alendronate, zoledronic acid and pamidronate)
- within two years of study entry
- aromatase inhibitors
- GnRH analogs
- glucocorticoids of at least 5 mg daily for one month or more
- anabolic steroids
- dilantin
- warfarin
- patients with diseases known to interfere with bone metabolism as hyperparathyroidism, untreated hyperthyroidism, osteomalacia, chronic liver disease, renal failure, hypercortisolism, malabsorption and immobilization
- those with current alcohol use of more than 3 drinks per day (62).
- history of documented coronary artery disease at high risk for recurrence
- Subjects with osteoporosis or a BMD T-score of -2.5 in the lumbar spine, total femur or femoral neck as well as those patients with a history of osteoporosis-related fractures (spine, hip or wrist) or vertebral deformities on lateral spine radiographs deemed as fragility fractures by the team principal investigator.
- history of documented coronary artery disease at high risk for recurrence, history of deep vein thrombosis and cerebrovascular event.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
Official title: CYP19A1 Gene and Pharmacogenetics of Response
Testosterone (T) replacement prevents bone loss and relieves symptoms associated with androgen deficiency in male patients with hypogonadism, but at the expense of an increase in prostate-related adverse events and in the hematocrit values above the normal which may lead to bad circulatory outcomes. Most of the effects of T on the male skeleton are mediated by its conversion to estradiol (E2) by the enzyme aromatase. Genetic variations in the aromatase (CYP19A1) gene result in enzymes with variable activity and variable levels of E2 and T. This project is designed to determine if genetic variations in the CYP19A1 gene will result in differences in the skeletal response and incidence of side effects from T treatment in patients with low T. A large number of male Veterans are on T. Results from this project will help identify patients who would benefit from the therapy from those at risk for side effects, and would definitely have an impact in the future care of these patients and male patients in general once genetic profiling becomes part of the standard of care.
Read the detailed description
Estrogen has been gaining recognition as the primary hormone that regulates the male skeleton. Estrogen in males is mainly derived from the conversion of testosterone to estradiol by the enzyme aromatase. Polymorphisms of the aromatase gene (CYP19A1) have been reported to result in variable enzyme activity resulting in variable hormonal profile and differences in bone mineral density (BMD) among the variants. These polymorphisms were also found to influence changes in BMD in response to hormone therapy in postmenopausal women and bone loss from aromatase inhibitors in women with breast cancer. It is possible that these same polymorphisms will also influence skeletal response to testosterone therapy in hypogonadal males given testosterone.
Among the side effects described for testosterone therapy, prostate-related events and an increase in hematocrit represent as the more common and the potentially more serious side effects. However, these side effects do not affect everybody, suggesting that a certain subgroup of patients is predisposed to these side effects. Because polymorphisms in the CYP19A1 gene result differences in activity among variants leading in variable substrate and product accumulation, the investigators hypothesize that these polymorphisms will influence the skeletal response and perhaps susceptibility to side effects from testosterone therapy. Thus the objectives of this proposal are: (1) To evaluate the influence of polymorphisms in the CYP19A1 gene on the skeletal response to testosterone in male patients with low testosterone, (2) To evaluate the influence of polymorphisms in the CYP19A1 gene on the susceptibility to side effects from testosterone therapy, (3) To evaluate the changes in functional activity of the aromatase enzyme in clinically significant CYP19A1 gene polymorphisms. The investigators propose to treat 105 patients with testosterone cypionate 200 mg IM every 2 weeks for an 18-month treatment period. The investigators will do serial measurements of BMD by dual energy X-ray absorptiometry, markers of bone turnover, hematocrit, prostate-specific antigen (PSA), prostate volume and hormonal assays. Changes in BMD and markers of bone turnover with testosterone treatment will be compared among the different CYP19A1 genotypes. The investigators will also compare changes in hematocrit, PSA and prostate volume among the different CYP19A1 genotypes. Changes in functional activity among the variants will be evaluated by CYP19 gene expression studies on the adipose tissues obtained from periumbilical fat biopsies, and by changes the in estradiol to testosterone ratio, a surrogate marker for aromatase activity. The investigators anticipate that variants with increase in activity will have relatively higher estradiol levels than less active variants resulting in greater increments in BMD. Meanwhile, less active variants will have relatively higher levels of testosterone than other variants and have greater increments in hematocrit. On the other hand, variants associated with higher estradiol to testosterone ratio will experience greater increases in PSA and prostate volume with therapy.
The incidence of testosterone deficiency goes up with aging and the presence of co-morbid conditions making male hypogonadism one of the common problems among patients attending the VA clinics who, are for the most part, elderly with various co-morbid conditions. Indeed, a large number of VA patients are already taking testosterone for hypogonadism, some of them primarily to prevent further bone loss. It is possible that some of these patients do not derive benefit from the drug while subjecting them to potential serious side effects. Results from this proposal will identify the genetic profiles of favorable responders from poor responders or those who might be more prone to serious side effects, thus, may impact the future care of male Veterans and hypogonadal patients in general, once genetic profiling becomes part of the standard of care.
- Conditions
- Hypogonadism
- Being tested
- Testosterone Cypionate
- Keywords
- testosterone
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone CypionateDrug
Also called depo testosterone
Testosterone cypionate was administered at 200 mg by intramuscular injection every 2 weeks.
DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-, (178)-. Its molecular formula is CvH400a, and the molecular weight of 412.61.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Testosterone Cypionate | Experimental | All patients who qualify for the study will receive testosterone cypionate Receives: Drug: Testosterone Cypionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene
Percent change in bone mineral density from baseline to 18 months
Measured: form baseline to 18 months
Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene
Percent change in bone mineral density from baseline to 18 months.
Measured: baseline to 18 months
Secondary outcomes (10)
Percent Change in Bone Mineral Density According to Body Mass Index (BMI)
Percent changes in bone mineral density from baseline
Measured: baseline to 18 months
Percent Change in Prostate-specific Antigen (PSA) According to the rs700518 Polymorphism of the CYP19A1 Gene
Percent change in PSA from baseline to 18 months
Measured: From baseline to 18 months
Percent Change in Prostate-specific Antigen (PSA) According to the rs1062033 Polymorphism of the CYP19A1 Gene
Percent change in PSA from baseline at 18 months
Measured: from baseline to 18 months
Percent Change in Hematocrit According to the Genotype of the 700518 Polymorphism of the CYP19A1gene
Percent change in hematocrit from baseline to 18 months
Measured: baseline to 18 months
Percent Change in Hematocrit According to re1062033 Polymorphism of the CYP19A1 Gene
Percent change in hematocrit from baseline to 18 months
Measured: Baseline to 18 months
Percent Change in Aromatase Gene Activity From the Buffy Coat According to the 700518 Polymorphism of the CYP19A1 Gene
Percent change in gene expression from baseline to 18 months
Measured: Baseline to 6 months
Percent Change in Bone Turnover Markers According to the rs700518 Polymorphism of the CYP19A1 Gene
Percent change in bone turnover from baseline to 18 months.
Measured: Baseline to 18 months
Percent Change in Bone Turnover Markers According to the rs1062033 Polymorphism of the CYP19A1 Gene
Percent change in bone turnover markers
Measured: Baseline to 18 months
Percent Change in Bone Mineral Density According the Presence of Diabetes Mellitus
Percent change in bone mineral density from baseline to 18 months
Measured: Baseline to 18 months
Percent Change in Bone Turnover Markers According the Presence of Diabetes Mellitus
Percent change in bone turnover markers from baseline to 18 months.
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study start1 Oct 2011
- Primary completion7 Nov 2016
- Study completion7 Nov 2017
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Reina C Villareal, MD, Principal investigator, New Mexico VA Health Care System, Albuquerque, NM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378299
- Sponsor's protocol ID
- SPLC-001-10S
- Status last verified
- Feb 2019
- First submitted
- 16 Jun 2011
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: People who ensure quality from the institutions where the research is being done, federal and other regulatory agencies will have access to all of the research data such as Food and Drug Administration (FDA) and Data Monitoring Committee (DMC). The purpose of collecting information covered under 38 U.S.C. 7332 is to conduct scientific research and no personnel involved in this study will identify, directly or indirectly, any individual patient or subject in any report of such research. The only research data that will leave the MEDVA MC will be emailed to the FDA and Data Monitoring Committee, and will include only data on subjects who developed side effects including heart attacks, strokes, high hematocrit, high PSA, psychiatric problems and other adverse events, and the results of their tests. None of the 18 HIPAA identifiers will be included.
Publications
Joad S, Ballato E, Deepika F, Gregori G, Fleires-Gutierrez AL, Colleluori G, Aguirre L, Chen R, Russo V, Fuenmayor Lopez VC, Qualls C, Villareal DT, Armamento-Villareal R. Hemoglobin A1c Threshold for Reduction in Bone Turnover in Men With Type 2 Diabetes Mellitus. Front Endocrinol (Lausanne). 2021 Dec 28;12:788107. doi: 10.3389/fendo.2021.788107. eCollection 2021.
PubMed 35027909Colleluori G, Aguirre L, Napoli N, Qualls C, Villareal DT, Armamento-Villareal R. Testosterone Therapy Effects on Bone Mass and Turnover in Hypogonadal Men with Type 2 Diabetes. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3058-e3068. doi: 10.1210/clinem/dgab181.
PubMed 33735389
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CYP19A1 Gene and Pharmacogenetics of Response
- ClinicalTrials.gov ID
- NCT01378299
- Acronym / sponsor ID
- SPLC-001-10S
- Conditions
- Hypogonadism
- Keywords
- testosterone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Baylor College of Medicine
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 7 Nov 2016 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testosterone (T) replacement prevents bone loss and relieves symptoms associated with androgen deficiency in male patients with hypogonadism, but at the expense of an increase in prostate-related adverse events and in the hematocrit values above the normal which may lead to bad circulatory outcomes. Most of the effects of T on the male skeleton are mediated by its conversion to estradiol (E2) by the enzyme aromatase. Genetic variations in the aromatase (CYP19A1) gene result in enzymes with variable activity and variable levels of E2 and T. This project is designed to determine if genetic variations in the CYP19A1 gene will result in differences in the skeletal response and incidence of side effects from T treatment in patients with low T. A large number of male Veterans are on T. Results from this project will help identify patients who would benefit from the therapy from those at risk for side effects, and would definitely have an impact in the future care of these patients and male patients in general once genetic profiling becomes part of the standard of care.
Detailed description
Estrogen has been gaining recognition as the primary hormone that regulates the male skeleton. Estrogen in males is mainly derived from the conversion of testosterone to estradiol by the enzyme aromatase. Polymorphisms of the aromatase gene (CYP19A1) have been reported to result in variable enzyme activity resulting in variable hormonal profile and differences in bone mineral density (BMD) among the variants. These polymorphisms were also found to influence changes in BMD in response to hormone therapy in postmenopausal women and bone loss from aromatase inhibitors in women with breast cancer. It is possible that these same polymorphisms will also influence skeletal response to testosterone therapy in hypogonadal males given testosterone.
Among the side effects described for testosterone therapy, prostate-related events and an increase in hematocrit represent as the more common and the potentially more serious side effects. However, these side effects do not affect everybody, suggesting that a certain subgroup of patients is predisposed to these side effects. Because polymorphisms in the CYP19A1 gene result differences in activity among variants leading in variable substrate and product accumulation, the investigators hypothesize that these polymorphisms will influence the skeletal response and perhaps susceptibility to side effects from testosterone therapy. Thus the objectives of this proposal are: (1) To evaluate the influence of polymorphisms in the CYP19A1 gene on the skeletal response to testosterone in male patients with low testosterone, (2) To evaluate the influence of polymorphisms in the CYP19A1 gene on the susceptibility to side effects from testosterone therapy, (3) To evaluate the changes in functional activity of the aromatase enzyme in clinically significant CYP19A1 gene polymorphisms. The investigators propose to treat 105 patients with testosterone cypionate 200 mg IM every 2 weeks for an 18-month treatment period. The investigators will do serial measurements of BMD by dual energy X-ray absorptiometry, markers of bone turnover, hematocrit, prostate-specific antigen (PSA), prostate volume and hormonal assays. Changes in BMD and markers of bone turnover with testosterone treatment will be compared among the different CYP19A1 genotypes. The investigators will also compare changes in hematocrit, PSA and prostate volume among the different CYP19A1 genotypes. Changes in functional activity among the variants will be evaluated by CYP19 gene expression studies on the adipose tissues obtained from periumbilical fat biopsies, and by changes the in estradiol to testosterone ratio, a surrogate marker for aromatase activity. The investigators anticipate that variants with increase in activity will have relatively higher estradiol levels than less active variants resulting in greater increments in BMD. Meanwhile, less active variants will have relatively higher levels of testosterone than other variants and have greater increments in hematocrit. On the other hand, variants associated with higher estradiol to testosterone ratio will experience greater increases in PSA and prostate volume with therapy.
The incidence of testosterone deficiency goes up with aging and the presence of co-morbid conditions making male hypogonadism one of the common problems among patients attending the VA clinics who, are for the most part, elderly with various co-morbid conditions. Indeed, a large number of VA patients are already taking testosterone for hypogonadism, some of them primarily to prevent further bone loss. It is possible that some of these patients do not derive benefit from the drug while subjecting them to potential serious side effects. Results from this proposal will identify the genetic profiles of favorable responders from poor responders or those who might be more prone to serious side effects, thus, may impact the future care of male Veterans and hypogonadal patients in general, once genetic profiling becomes part of the standard of care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Testosterone Cypionate | Experimental | Drug: Testosterone CypionateAll patients who qualify for the study will receive testosterone cypionate |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male Veterans with low total testosterone (<300 ng/dl) as defined by the Endocrine Society, who are between 40-75 years of age.
- These patients must be ambulatory; and be willing and able to provide written informed consent.
Key exclusion criteria (23 listed)
- history of prostate cancer, breast cancer
- history of testicular disease
- untreated sleep apnea
- any ongoing illness that, in the opinion of the investigator, could prevent the subject from completing the study
- patients with a hematocrit of more than 50% (2010 Endocrine Society Guidelines)
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 CypionateAlso: depo testosteroneTestosterone cypionate was administered at 200 mg by intramuscular injection every 2 weeks. DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-, (178)-. Its molecular formula is CvH400a, and the molecular weight of 412.61. | Drug | Arm 1: Testosterone Cypionate |
Primary outcome
Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene
Time frame: form baseline to 18 months
Percent change in bone mineral density from baseline to 18 months
Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene
Time frame: baseline to 18 months
Percent change in bone mineral density from baseline to 18 months.
10 secondary outcomes
Percent Change in Bone Mineral Density According to Body Mass Index (BMI)
Time frame: baseline to 18 months
Percent Change in Prostate-specific Antigen (PSA) According to the rs700518 Polymorphism of the CYP19A1 Gene
Time frame: From baseline to 18 months
Percent Change in Prostate-specific Antigen (PSA) According to the rs1062033 Polymorphism of the CYP19A1 Gene
Time frame: from baseline to 18 months
Percent Change in Hematocrit According to the Genotype of the 700518 Polymorphism of the CYP19A1gene
Time frame: baseline to 18 months
Percent Change in Hematocrit According to re1062033 Polymorphism of the CYP19A1 Gene
Time frame: Baseline to 18 months
Percent Change in Aromatase Gene Activity From the Buffy Coat According to the 700518 Polymorphism of the CYP19A1 Gene
Time frame: Baseline to 6 months
Percent Change in Bone Turnover Markers According to the rs700518 Polymorphism of the CYP19A1 Gene
Time frame: Baseline to 18 months
Percent Change in Bone Turnover Markers According to the rs1062033 Polymorphism of the CYP19A1 Gene
Time frame: Baseline to 18 months
Percent Change in Bone Mineral Density According the Presence of Diabetes Mellitus
Time frame: Baseline to 18 months
Percent Change in Bone Turnover Markers According the Presence of Diabetes Mellitus
Time frame: Baseline to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35027909Joad S, Ballato E, Deepika F, Gregori G, Fleires-Gutierrez AL, Colleluori G, Aguirre L, Chen R, Russo V, Fuenmayor Lopez VC, Qualls C, Villareal DT, Armamento-Villareal R. Hemoglobin A1c Threshold for Reduction in Bone Turnover in Men With Type 2 Diabetes Mellitus. Front Endocrinol (Lausanne). 2021 Dec 28;12:788107. doi: 10.3389/fendo.2021.788107. eCollection 2021.
- Derived from this study: PubMed 33735389Colleluori G, Aguirre L, Napoli N, Qualls C, Villareal DT, Armamento-Villareal R. Testosterone Therapy Effects on Bone Mass and Turnover in Hypogonadal Men with Type 2 Diabetes. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3058-e3068. doi: 10.1210/clinem/dgab181.
- Individual participant dataSharing planned: Yes. People who ensure quality from the institutions where the research is being done, federal and other regulatory agencies will have access to all of the research data such as Food and Drug Administration (FDA) and Data Monitoring Committee (DMC). The purpose of collecting information covered under 38 U.S.C. 7332 is to conduct scientific research and no personnel involved in this study will identify, directly or indirectly, any individual patient or subject in any report of such research. The only research data that will leave the MEDVA MC will be emailed to the FDA and Data Monitoring Committee, and will include only data on subjects who developed side effects including heart attacks, strokes, high hematocrit, high PSA, psychiatric problems and other adverse events, and the results of their tests. None of the 18 HIPAA identifiers will be included.
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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.
Reina C Villareal, MD principal investigator
New Mexico VA Health Care System, Albuquerque, NM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Testosterone Cypionate in people with Hypogonadism, run by VA Office of Research and Development at 2 sites 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 2 inclusion and 23 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 5 Mar 2019). 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?
Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene (time frame: form baseline to 18 months). The study lists 2 primary outcomes in all. 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 NCT01378299, which also lists 2 linked publications.
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 5 Mar 2019.