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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR TESTOSTERONE CYPIONATE

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Clinical Trials for Testosterone Cypionate

Trial ID Title Status Sponsor Phase Summary
NCT01084759 A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer Completed Sidney Kimmel Comprehensive Cancer Center N/A The objective of the study is to determine if men with evidence of progressive prostate cancer while on chronic androgen ablation of ≥ 1 year duration will exhibit a clinical response following administration of parenteral testosterone and oral etoposide. Treatment Plan: Eligible patients will continue on androgen ablative therapy with luteinizing hormone-releasing hormone (LHRH) agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy). This dose was selected based on data demonstrating that it produces an initial supraphysiologic serum level of testosterone (i.e. > 3-5 times normal level) with eugonadal levels achieved at the end of two weeks. Beginning the day of the testosterone injection, patients will also receive oral etoposide 100 mg/day in divided doses (50 mg q 12h) x 14 days out of 28 days per cycle. After 3 months on therapy, patients will have repeat prostate specific antigen (PSA) and bone/computed tomography (CT) scans to establish the effect of combined testosterone and etoposide treatment on these parameters (i.e. "testosterone effect baseline"). Patients with sustained elevations in PSA ≥ 50% above pre-testosterone treatment PSA levels after the initial three months of testosterone and etoposide therapy will not receive continued therapy and will come off study. Patients with PSA levels less than the peak serum PSA level seen over the three month period (PSA decline) or patients with PSA ≤ 50% of pretreatment baseline will receive a second 3 month course of monthly testosterone and etoposide therapy until evidence of disease progression. Disease progression is defined as a PSA increase above the PSA level obtained after 3 months on testosterone treatment over two successive measurements 2 weeks apart or evidence of new lesions or progression on bone/CT scans compared to baseline studies. Patients who respond to initial treatment with testosterone and etoposide and then show signs of progression will have the option of retreatment with testosterone alone after a period of 3 months or greater off of the original therapy.
NCT01378299 CYP19A1 Gene and Pharmacogenetics of Response to Testosterone Therapy Active, not recruiting Baylor College of Medicine Phase 1 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.
NCT01378299 CYP19A1 Gene and Pharmacogenetics of Response to Testosterone Therapy Active, not recruiting VA Office of Research and Development Phase 1 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.
NCT01750398 Bipolar Androgen-based Therapy for Prostate Cancer (BAT) Completed Sidney Kimmel Comprehensive Cancer Center Phase 2 The purpose of this study is to determine the safety and clinical effects of alternating androgen deprivation therapy with testosterone therapy in men with recurrent prostate cancer as first line hormonal therapy, to assess the effect of alternating therapy on quality of life and metabolic changes associated with androgen-deprivation therapy.
NCT02090114 RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistant (The RESTORE Study) Recruiting National Cancer Institute (NCI) Phase 2 Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide or abiraterone in men with metastatic CRPC who previously progressed on either of these agents. The study will enroll two cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A); and men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B).
NCT02090114 RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistant (The RESTORE Study) Recruiting Sidney Kimmel Comprehensive Cancer Center Phase 2 Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide or abiraterone in men with metastatic CRPC who previously progressed on either of these agents. The study will enroll two cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A); and men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B).
NCT02229617 Subcutaneous Testosterone Project Completed Vancouver Coastal Health Research Institute Phase 1/Phase 2 For people who identify as transgender, there is a strong sense that they were born into the wrong body and that their outward looking body does not match how they truly feel about themselves. They feel male, not female and have always felt that way. There is a great deal of discomfort or dysphoria about looking and feeling female, and there is a strong desire to achieve a more masculine appearance. While surgery, clothing and hair for example, can help a person appear more like a male, many transgender males will want to take testosterone to make them feel and look more masculine. This usually involves injecting testosterone into a muscle every 1-2 weeks for many years. Intramuscular injections can often be uncomfortable or painful, and requires the patient to be taught how to inject themselves. Or somebody else has to do it. There is a growing trend in some transgender men to give their injection just below the skin or subcutaneously (like insulin in a diabetic), because it is less uncomfortable but we don't really know if testosterone gets into the blood in the same way. At least one clinic in the US already suggests that patients can use the subcutaneous method but there is almost no research to show it's the same as intramuscular. Our project will be looking at a small group of transgender males who are already on intramuscular testosterone and then switch them over to the same dose of subcutaneous testosterone, and then compare their levels of testosterone. If those levels are similar, then patients may chose the less uncomfortable subcutaneous injection.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Testosterone Cypionate

Condition Name

Condition Name for Testosterone Cypionate
Intervention Trials
Prostate Cancer 4
Recurrent Prostate Cancer 1
Metastatic Prostate Cancer 1
Hypogonadism 1
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Condition MeSH

Condition MeSH for Testosterone Cypionate
Intervention Trials
Prostatic Neoplasms 6
Gender Dysphoria 1
Hypogonadism 1
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Clinical Trial Locations for Testosterone Cypionate

Trials by Country

Trials by Country for Testosterone Cypionate
Location Trials
United States 7
Canada 1
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Trials by US State

Trials by US State for Testosterone Cypionate
Location Trials
Maryland 6
Texas 1
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Clinical Trial Progress for Testosterone Cypionate

Clinical Trial Phase

Clinical Trial Phase for Testosterone Cypionate
Clinical Trial Phase Trials
Phase 2 4
Phase 1/Phase 2 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Testosterone Cypionate
Clinical Trial Phase Trials
Completed 3
Recruiting 3
Not yet recruiting 1
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Clinical Trial Sponsors for Testosterone Cypionate

Sponsor Name

Sponsor Name for Testosterone Cypionate
Sponsor Trials
Sidney Kimmel Comprehensive Cancer Center 5
United States Department of Defense 1
University of British Columbia 1
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Sponsor Type

Sponsor Type for Testosterone Cypionate
Sponsor Trials
Other 9
U.S. Fed 2
Industry 1
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