Trial Outcomes & Findings for CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy (NCT NCT01378299)
NCT ID: NCT01378299
Last Updated: 2019-03-05
Results Overview
Percent change in bone mineral density from baseline to 18 months
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
105 participants
Primary outcome timeframe
form baseline to 18 months
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Arm 1: Testosterone Cypionate
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into different groups of BMI.
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 412.61.is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
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|---|---|
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Overall Study
STARTED
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105
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Overall Study
BMI group1
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38
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Overall Study
BMI Group 2
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40
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Overall Study
BMI Group 3
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27
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Overall Study
COMPLETED
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74
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Overall Study
NOT COMPLETED
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31
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants were divided into BMI groups.
Baseline characteristics by cohort
| Measure |
Arm 1: Testosterone Cypionate
n=105 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into different groups of BMI.
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 mole
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|---|---|
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Age, Continuous
BMI group 1
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61.7 years
STANDARD_DEVIATION 8.5 • n=105 Participants
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Age, Continuous
BMI group 2
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57.3 years
STANDARD_DEVIATION 8.7 • n=105 Participants
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Age, Continuous
BMI group 3
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60.0 years
STANDARD_DEVIATION 7.4 • n=105 Participants
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Sex: Female, Male
BMI group 1 · Female
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0 Participants
n=38 Participants • Participants were divided into BMI groups.
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Sex: Female, Male
BMI group 1 · Male
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38 Participants
n=38 Participants • Participants were divided into BMI groups.
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Sex: Female, Male
BMI group 2 · Female
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0 Participants
n=40 Participants • Participants were divided into BMI groups.
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Sex: Female, Male
BMI group 2 · Male
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40 Participants
n=40 Participants • Participants were divided into BMI groups.
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Sex: Female, Male
BMI group 3 · Female
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0 Participants
n=27 Participants • Participants were divided into BMI groups.
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Sex: Female, Male
BMI group 3 · Male
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27 Participants
n=27 Participants • Participants were divided into BMI groups.
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Race/Ethnicity, Customized
Caucasians
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45 Participants
n=105 Participants
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Race/Ethnicity, Customized
Blacks
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11 Participants
n=105 Participants
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Race/Ethnicity, Customized
Hispanics
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33 Participants
n=105 Participants
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Race/Ethnicity, Customized
Asian
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1 Participants
n=105 Participants
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Race/Ethnicity, Customized
American Indian
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1 Participants
n=105 Participants
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Race/Ethnicity, Customized
Not reported
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14 Participants
n=105 Participants
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Region of Enrollment
United States
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105 Participants
n=105 Participants
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Body mass index
BMI group 1
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27.2 kg/m2
STANDARD_DEVIATION 1.9 • n=105 Participants
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Body mass index
BMI group 2
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32.1 kg/m2
STANDARD_DEVIATION 1.4 • n=105 Participants
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Body mass index
BMI group 3
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39.8 kg/m2
STANDARD_DEVIATION 3.9 • n=105 Participants
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patients with diabetes mellitus
patients with diabetes mellitus
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49 Participants
n=105 Participants
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patients with diabetes mellitus
patients without diabetes mellitus
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56 Participants
n=105 Participants
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aromatase activity as assessed using estradiol to testosterone ratio
Tertile 1
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0.069 estradiol to testosterone ratio
STANDARD_DEVIATION 0.04 • n=29 Participants • Only the first 87 participants analyzed for this assessment
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aromatase activity as assessed using estradiol to testosterone ratio
Tertile 2
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0.25 estradiol to testosterone ratio
STANDARD_DEVIATION 0.07 • n=29 Participants • Only the first 87 participants analyzed for this assessment
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aromatase activity as assessed using estradiol to testosterone ratio
Tertile 3
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1.37 estradiol to testosterone ratio
STANDARD_DEVIATION 1.12 • n=29 Participants • Only the first 87 participants analyzed for this assessment
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PRIMARY outcome
Timeframe: form baseline to 18 monthsPopulation: Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis. The data from 84 subjects were available for analysis; 15 in the GG, 44 in the GA and 25 in the AA genotype.
Percent change in bone mineral density from baseline to 18 months
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=15 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=44 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
n=25 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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|---|---|---|---|
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Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene
Lumbar spine
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3.69 percent change
Standard Deviation 0.87
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4.13 percent change
Standard Deviation 0.52
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3.82 percent change
Standard Deviation 0.70
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Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene
Total hip
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0.38 percent change
Standard Deviation 0.93
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0.93 percent change
Standard Deviation 0.49
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0.08 percent change
Standard Deviation 0.66
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Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene
Femoral neck
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-1.09 percent change
Standard Deviation 1.28
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1.51 percent change
Standard Deviation 0.69
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-1.25 percent change
Standard Deviation 0.91
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PRIMARY outcome
Timeframe: baseline to 18 monthsPopulation: Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis . The data of 82 subjects were available for analysis; 14 in the GG, 38 in the GC and 32 in the CC genotype.
Percent change in bone mineral density from baseline to 18 months.
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=14 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=38 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
n=32 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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|---|---|---|---|
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Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene
LUMBAR SPINE
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4.72 PERCENT CHANGE
Standard Deviation 0.91
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2.85 PERCENT CHANGE
Standard Deviation 0.56
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3.74 PERCENT CHANGE
Standard Deviation 0.63
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Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene
FEMORAL NECK
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-1.04 PERCENT CHANGE
Standard Deviation 1.31
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0.64 PERCENT CHANGE
Standard Deviation 0.81
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0.22 PERCENT CHANGE
Standard Deviation 0.96
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Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene
TOTAL HIP
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0.33 PERCENT CHANGE
Standard Deviation 0.84
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0.70 PERCENT CHANGE
Standard Deviation 0.50
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0.64 PERCENT CHANGE
Standard Deviation 0.56
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SECONDARY outcome
Timeframe: baseline to 18 monthsPopulation: Analysis was by intention to treat with the last value carry forward. Thirty subjects in BMI group 1, 31 in BMI group 2 and 23 subjects in BMI groups 3 have complete dataset available for analysis. There were a total 84 patients who were able to provide data for this outcome at 18 months.
Percent changes in bone mineral density from baseline
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=30 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=31 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
n=23 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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|---|---|---|---|
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Percent Change in Bone Mineral Density According to Body Mass Index (BMI)
lumbar spine
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3.00 Percent change
Standard Error 0.97
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4.90 Percent change
Standard Error 0.96
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3.90 Percent change
Standard Error 1.24
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Percent Change in Bone Mineral Density According to Body Mass Index (BMI)
Total hip
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0.14 Percent change
Standard Error 0.56
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1.74 Percent change
Standard Error 0.55
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-0.27 Percent change
Standard Error 0.64
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Percent Change in Bone Mineral Density According to Body Mass Index (BMI)
femoral neck
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0.71 Percent change
Standard Error 0.83
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-0.33 Percent change
Standard Error 0.86
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0.16 Percent change
Standard Error 0.97
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SECONDARY outcome
Timeframe: From baseline to 18 monthsPopulation: More participants came for their 6-month blood test than for other outcomes e.g. BMD. Since our analysis was intention to treat with the last value carry forward, there were more patients with evaluable PSA data at 18 months, as some patients who had PSA but had no BMD testing etc. who dropped out of the study were also included in the analysis.
Percent change in PSA from baseline to 18 months
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=17 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=46 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
n=26 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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|---|---|---|---|
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Percent Change in Prostate-specific Antigen (PSA) According to the rs700518 Polymorphism of the CYP19A1 Gene
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105.78 percent change
Standard Deviation 167.93
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58.52 percent change
Standard Deviation 76.14
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44.44 percent change
Standard Deviation 59.92
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SECONDARY outcome
Timeframe: from baseline to 18 monthsPopulation: More participants came for their 6-month blood test than for other outcomes e.g. BMD. Since our analysis was intention to treat with the last value carry forward, there were more patients with evaluable PSA data at 18 months, as some patients who had PSA but had no BMD testing etc. who dropped out of the study were also included in the analysis.
Percent change in PSA from baseline at 18 months
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=17 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=46 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
n=26 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
|---|---|---|---|
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Percent Change in Prostate-specific Antigen (PSA) According to the rs1062033 Polymorphism of the CYP19A1 Gene
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85.15 precent change
Standard Deviation 23.84
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62.86 precent change
Standard Deviation 15.74
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52.93 precent change
Standard Deviation 17.11
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SECONDARY outcome
Timeframe: baseline to 18 monthsPopulation: Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis. The data of 85 subjects were available for analysis; 16 subjects in the GG, 43 in the GC and 26 subjects in the CC genotype.
Percent change in hematocrit from baseline to 18 months
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=16 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=43 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
n=26 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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|---|---|---|---|
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Percent Change in Hematocrit According to the Genotype of the 700518 Polymorphism of the CYP19A1gene
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11.32 Percent change
Standard Deviation 2.21
|
9.71 Percent change
Standard Deviation 1.35
|
9.41 Percent change
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Baseline to 18 monthsPopulation: Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis. The data of 85 subjects were available for analysis; 15 subjects in the GG, 37 in the GC and 33 subjects in the CC genotype.
Percent change in hematocrit from baseline to 18 months
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=15 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=37 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
n=33 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
|---|---|---|---|
|
Percent Change in Hematocrit According to re1062033 Polymorphism of the CYP19A1 Gene
|
11.56 percent change
Standard Deviation 2.28
|
9.67 percent change
Standard Deviation 1.45
|
9.46 percent change
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Gene expression studies were successful in 27 samples; 6 in the GG, 17 in the GA and 4 in the AA genotype.
Percent change in gene expression from baseline to 18 months
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=6 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=17 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
n=4 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
|---|---|---|---|
|
Percent Change in Aromatase Gene Activity From the Buffy Coat According to the 700518 Polymorphism of the CYP19A1 Gene
|
25.0 percent change
Standard Deviation 120.0
|
65.25 percent change
Standard Deviation 71.29
|
113.33 percent change
Standard Deviation 146.97
|
SECONDARY outcome
Timeframe: Baseline to 18 monthsPopulation: Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis. The data of 79 subjects were analyzed; 15 in the GG, 43 in the GA and 21 in the AA genotype.
Percent change in bone turnover from baseline to 18 months.
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=15 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=43 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
n=21 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
|---|---|---|---|
|
Percent Change in Bone Turnover Markers According to the rs700518 Polymorphism of the CYP19A1 Gene
C-teloepetide
|
41.47 perecent change
Standard Deviation 16.33
|
3.35 perecent change
Standard Deviation 9.64
|
-9.75 perecent change
Standard Deviation 13.80
|
|
Percent Change in Bone Turnover Markers According to the rs700518 Polymorphism of the CYP19A1 Gene
Osteocalcin
|
12.40 perecent change
Standard Deviation 133.13
|
-31.22 perecent change
Standard Deviation 148.00
|
-7.27 perecent change
Standard Deviation 112.06
|
SECONDARY outcome
Timeframe: Baseline to 18 monthsPopulation: Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis. The data of 79 subjects with acceptable assay coefficient of variability were available for analysis; 15 subjects in the GG, 37 in the GC and 27 in the CC genotype.
Percent change in bone turnover markers
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=15 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=37 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
n=27 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
|---|---|---|---|
|
Percent Change in Bone Turnover Markers According to the rs1062033 Polymorphism of the CYP19A1 Gene
C-telopeptide
|
48.96 Percent change
Standard Deviation 98.42
|
5.89 Percent change
Standard Deviation 48.82
|
-14.49 Percent change
Standard Deviation 51.05
|
|
Percent Change in Bone Turnover Markers According to the rs1062033 Polymorphism of the CYP19A1 Gene
Osteocalcin
|
33.59 Percent change
Standard Deviation 118.59
|
-20.59 Percent change
Standard Deviation 128.37
|
-26.96 Percent change
Standard Deviation 144.48
|
SECONDARY outcome
Timeframe: Baseline to 18 monthsPopulation: Analysis was by intention to treat with the last value carry forward. Thirty-nine subjects with diabetes mellitus group and 45 without diabetes mellitus have complete dataset available for analysis.
Percent change in bone mineral density from baseline to 18 months
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=39 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=45 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
|---|---|---|---|
|
Percent Change in Bone Mineral Density According the Presence of Diabetes Mellitus
LUMBAR SPINE
|
4.05 Percent change
Standard Deviation 0.60
|
3.28 Percent change
Standard Deviation 0.51
|
—
|
|
Percent Change in Bone Mineral Density According the Presence of Diabetes Mellitus
TOTAL HIP
|
1.81 Percent change
Standard Deviation 0.61
|
0.53 Percent change
Standard Deviation 0.49
|
—
|
|
Percent Change in Bone Mineral Density According the Presence of Diabetes Mellitus
FEMORAL NECK
|
1.63 Percent change
Standard Deviation 0.95
|
-0.55 Percent change
Standard Deviation 0.79
|
—
|
SECONDARY outcome
Timeframe: Baseline to 18 monthsPopulation: Analysis was by intention to treat with the last value carry forward. Thirty-seven subjects with diabetes mellitus group and 41 without diabetes mellitus have complete dataset available for analysis.
Percent change in bone turnover markers from baseline to 18 months.
Outcome measures
| Measure |
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene
n=37 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
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 mole
|
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene
n=41 Participants
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
Subjects were divided into the different genotypes for the rs700518 polymorphism of the CYP19A1 gene.
|
|---|---|---|---|
|
Percent Change in Bone Turnover Markers According the Presence of Diabetes Mellitus
C-telopeptide
|
73.55 Percentage Changes
Standard Error 22.88
|
2.05 Percentage Changes
Standard Error 16.22
|
—
|
|
Percent Change in Bone Turnover Markers According the Presence of Diabetes Mellitus
Osteocalcin
|
20.54 Percentage Changes
Standard Error 15.64
|
-6.62 Percentage Changes
Standard Error 10.54
|
—
|
Adverse Events
Arm 1: Testosterone Cypionate
Serious events: 18 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Testosterone Cypionate
n=105 participants at risk
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: 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 mole
|
|---|---|
|
Nervous system disorders
stroke
|
1.9%
2/105 • 18 months
|
|
Infections and infestations
abscess
|
0.95%
1/105 • 18 months
|
|
Gastrointestinal disorders
appendicitis
|
0.95%
1/105 • 18 months
|
|
Gastrointestinal disorders
GI tract perforation
|
0.95%
1/105 • 18 months
|
|
Infections and infestations
infection of an appendectomy wound
|
0.95%
1/105 • 18 months
|
|
Psychiatric disorders
pyschiatric ilness
|
3.8%
4/105 • 18 months
|
|
Musculoskeletal and connective tissue disorders
knee arthroscopy
|
0.95%
1/105 • 18 months
|
|
Musculoskeletal and connective tissue disorders
knee replacement surgery
|
0.95%
1/105 • 18 months
|
|
Cardiac disorders
coronary stent
|
1.9%
2/105 • 18 months
|
|
Cardiac disorders
atypical chest pain
|
0.95%
1/105 • 18 months
|
|
Cardiac disorders
new-onset atrial fibrillation
|
0.95%
1/105 • 18 months
|
|
Cardiac disorders
myocardial infarction
|
1.9%
2/105 • 18 months
|
Other adverse events
| Measure |
Arm 1: Testosterone Cypionate
n=105 participants at risk
All patients who qualify for the study will receive testosterone cypionate
Testosterone Cypionate: 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 mole
|
|---|---|
|
Cardiac disorders
Congestive heart failure
|
0.95%
1/105 • 18 months
|
|
Gastrointestinal disorders
appendicitis
|
0.95%
1/105 • 18 months
|
|
Gastrointestinal disorders
diverticulitis
|
1.9%
2/105 • 18 months
|
|
Gastrointestinal disorders
heartburn
|
0.95%
1/105 • 18 months
|
|
Hepatobiliary disorders
gallstones
|
0.95%
1/105 • 18 months
|
|
Gastrointestinal disorders
infected appendectomy wound
|
0.95%
1/105 • 18 months
|
|
Infections and infestations
infected spider bite
|
0.95%
1/105 • 18 months
|
|
Infections and infestations
shingles
|
0.95%
1/105 • 18 months
|
|
Infections and infestations
cellulitis
|
0.95%
1/105 • 18 months
|
|
Blood and lymphatic system disorders
high hematocrit
|
8.6%
9/105 • 18 months
|
|
Blood and lymphatic system disorders
hemochromatosis
|
0.95%
1/105 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
0.95%
1/105 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.95%
1/105 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
lung carcinoma
|
0.95%
1/105 • 18 months
|
|
Reproductive system and breast disorders
priapism
|
0.95%
1/105 • 18 months
|
|
Reproductive system and breast disorders
mastitis
|
0.95%
1/105 • 18 months
|
|
Renal and urinary disorders
prostate enlargement
|
0.95%
1/105 • 18 months
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.95%
1/105 • 18 months
|
|
Skin and subcutaneous tissue disorders
acne
|
0.95%
1/105 • 18 months
|
|
Skin and subcutaneous tissue disorders
laceration
|
2.9%
3/105 • 18 months
|
|
Psychiatric disorders
mood swings
|
0.95%
1/105 • 18 months
|
|
Psychiatric disorders
irritability
|
0.95%
1/105 • 18 months
|
|
Psychiatric disorders
depression
|
0.95%
1/105 • 18 months
|
|
Nervous system disorders
headache
|
0.95%
1/105 • 18 months
|
|
Musculoskeletal and connective tissue disorders
ingrown toenail
|
0.95%
1/105 • 18 months
|
|
Musculoskeletal and connective tissue disorders
heel pain
|
0.95%
1/105 • 18 months
|
|
Musculoskeletal and connective tissue disorders
arthroplasty
|
2.9%
3/105 • 18 months
|
|
Musculoskeletal and connective tissue disorders
foot pain
|
0.95%
1/105 • 18 months
|
|
Musculoskeletal and connective tissue disorders
vertebral fracture
|
0.95%
1/105 • 18 months
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
2.9%
3/105 • 18 months
|
|
Musculoskeletal and connective tissue disorders
excision of bone spur
|
1.9%
2/105 • 18 months
|
|
Musculoskeletal and connective tissue disorders
knee replacement
|
0.95%
1/105 • 18 months
|
|
General disorders
sleep apnea
|
0.95%
1/105 • 18 months
|
|
Injury, poisoning and procedural complications
back pain
|
0.95%
1/105 • 18 months
|
|
Injury, poisoning and procedural complications
retinal injury
|
0.95%
1/105 • 18 months
|
Additional Information
Reina Villareal, MD
Michael E. DeBakey VA Medical Center
Phone: 713-794-7534
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place