Hypogonadism, Male, Testosterone Deficiency
Conditions
Brief summary
In this randomized, cross-over study 20 subjects who are undergoing testosterone (T) therapy for the treatment of T deficiency will receive both subcutaneous testosterone therapy and intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM injection and one group will receive an IM injection followed by a SQ injection. The primary objective of this study is to measure testosterone concentration in men after these two treatment routes and determine if there are any significant differences due to modes of administration. Endpoints will include total serum testosterone and calculated free testosterone. A questionnaire will also be administered to assess overall patient experience with each route of administration.
Detailed description
Subjects planning to initiate testosterone treatment via injection at MHB will be consented into the study. Upon enrollment in the study, the randomization will be completed for each subject. Blood collection will occur before each injection. Subjects will rate pain on the Likert scale following each injection. After treatment with the first mode of T administration (SQ or IM depending on randomization), subjects will come in for blood draws 3 days and 7 days following the injection. Two weeks after the initial injection, subjects will come in for treatment with the second mode of T administration (SQ or IM depending on randomization). Subjects will come in for blood draws 3 days and 7 days following the second injection. Two weeks after the second injection, subjects will complete an end of study assessment with an Investigator and will complete a survey assessing their satisfaction with treatment. Subjects will likely continue testosterone therapy at Men's Health Boston after completion of the study.
Interventions
DRUGTestosterone
Testosterone cypionate injection
Sponsors
Men's Health Boston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Ability to read, write, and understand English * Age greater than or equal to 18 * Diagnosed with testosterone deficiency * Pre-enrollment testosterone concentration of less than 350 ng/dL * Planning to initiate testosterone treatment at MHB * Willing to be followed at MHB for at least one month * Willing to provide informed consent for this study
Exclusion criteria
* Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 12 weeks * American Urological Association Prostate Symptom score of 15 or greater or significant prostatic symptoms * History of carcinoma, tumors or induration of the prostate or the male mammary gland, including suspicion thereof * Pre-enrollment serum PSA more than 4 ng/ml * Serious psychiatric disease or uncontrolled medical illness, as suspected from the history or clinical examination * Used any sex hormones or steroidal anabolic drug supplements within 28 days before pre-enrollment testosterone collection or at any time throughout the study * Incapable of giving informed consent or complying with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Levels of Serum Total Testosterone Concentration | Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 | Blood samples measured by Beckman assays and equipment. |
| Change in Levels of Serum Calculated Free T Concentration | Last visit ( Visit 7) | Blood samples measured by Beckman assays and equipment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Levels of Serum FSH | Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 | Blood samples measured by Beckman assays and equipment. |
| Change in Levels of Serum SHBG | Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 | Blood samples measured by Beckman assays and equipment. |
| Change in Level of Serum PSA | Last visit (Visit 7) | Blood samples measured by Beckman assays and equipment. |
| Change in Levels of Serum Estradiol | Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 | Blood samples measured by Beckman assays and equipment. |
| Change in Low Testosterone Questionnaire Responses | after last vist #7 | Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale is 1-5 (strongly disagree to strongly agree) Lower scores are better |
| Change in International Prostate Symptom Scores | after last vist #7 | Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale 0-35, from Mild to Severe Lower score is better |
| Change in Levels of Whole Blood Hematocrit | Last visit (Visit 7) | Blood samples measured by Quest assays and equipment. |
| Change in Levels of Serum LH | Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 | Blood samples measured by Beckman assays and equipment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SQ-IM Subcutaneous testosterone injection followed by intramuscular testosterone injection
Testosterone: Testosterone cypionate injection | 0 |
| IM-SQ Intramuscular testosterone injection followed by subcutaneous testosterone injection
Testosterone: Testosterone cypionate injection | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Total | IM-SQ | SQ-IM |
|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 0 | 44 years STANDARD_DEVIATION 0 | — |
| Estradiol (E2) | 24.5 pg/ml | 24.5 pg/ml | — |
| Hemophagocytic lymphohistiocytosis(hLH) | 3 miu/ml | 3 miu/ml | — |
| Human Follicle Stimulating Hormone (hFSH) | 3.5 miu/ml | 3.5 miu/ml | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | — |
| Region of Enrollment United States | 1 participants | 1 participants | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
| Sex hormone binding globulin(SHBG) | 27.3 nmol/l | 27.3 nmol/l | — |
| Testosterone | 317.1 ng/dl | 317.1 ng/dl | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Change in Levels of Serum Calculated Free T Concentration
Blood samples measured by Beckman assays and equipment.
Time frame: Last visit ( Visit 7)
Population: loss to follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SQ | Change in Levels of Serum Calculated Free T Concentration | 0.84 ng/dL |
| IM | Change in Levels of Serum Calculated Free T Concentration | 14.74 ng/dL |
Primary
Change in Levels of Serum Total Testosterone Concentration
Blood samples measured by Beckman assays and equipment.
Time frame: Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7
Population: loss to follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SQ | Change in Levels of Serum Total Testosterone Concentration | visit 2 | NA ng/dl |
| SQ | Change in Levels of Serum Total Testosterone Concentration | visit 3 | NA ng/dl |
| SQ | Change in Levels of Serum Total Testosterone Concentration | visit 4 | 203.5 ng/dl |
| SQ | Change in Levels of Serum Total Testosterone Concentration | vist 5 | 1367.9 ng/dl |
| SQ | Change in Levels of Serum Total Testosterone Concentration | visit 6 | 980.8 ng/dl |
| SQ | Change in Levels of Serum Total Testosterone Concentration | visit 7 | 144.7 ng/dl |
| IM | Change in Levels of Serum Total Testosterone Concentration | visit 6 | NA ng/dl |
| IM | Change in Levels of Serum Total Testosterone Concentration | visit 2 | 1043.6 ng/dl |
| IM | Change in Levels of Serum Total Testosterone Concentration | vist 5 | NA ng/dl |
| IM | Change in Levels of Serum Total Testosterone Concentration | visit 3 | 785.7 ng/dl |
| IM | Change in Levels of Serum Total Testosterone Concentration | visit 7 | NA ng/dl |
| IM | Change in Levels of Serum Total Testosterone Concentration | visit 4 | NA ng/dl |
Secondary
Change in International Prostate Symptom Scores
Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale 0-35, from Mild to Severe Lower score is better
Time frame: after last vist #7
Population: loss to follow up
Secondary
Change in Level of Serum PSA
Blood samples measured by Beckman assays and equipment.
Time frame: Last visit (Visit 7)
Population: loss to follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SQ | Change in Level of Serum PSA | 0.25 ng/mL |
| IM | Change in Level of Serum PSA | 0.02 ng/mL |
Secondary
Change in Levels of Serum Estradiol
Blood samples measured by Beckman assays and equipment.
Time frame: Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7
Population: loss to follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SQ | Change in Levels of Serum Estradiol | visit 2 | NA pg/mL |
| SQ | Change in Levels of Serum Estradiol | visit 3 | NA pg/mL |
| SQ | Change in Levels of Serum Estradiol | visit 4 | 30.06 pg/mL |
| SQ | Change in Levels of Serum Estradiol | visit 5 | 45.12 pg/mL |
| SQ | Change in Levels of Serum Estradiol | visit 6 | 64.74 pg/mL |
| SQ | Change in Levels of Serum Estradiol | visit 7 | 25.99 pg/mL |
| IM | Change in Levels of Serum Estradiol | visit 6 | NA pg/mL |
| IM | Change in Levels of Serum Estradiol | visit 2 | 70.03 pg/mL |
| IM | Change in Levels of Serum Estradiol | visit 5 | NA pg/mL |
| IM | Change in Levels of Serum Estradiol | visit 3 | 52.00 pg/mL |
| IM | Change in Levels of Serum Estradiol | visit 7 | NA pg/mL |
| IM | Change in Levels of Serum Estradiol | visit 4 | NA pg/mL |
Secondary
Change in Levels of Serum FSH
Blood samples measured by Beckman assays and equipment.
Time frame: Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7
Population: loss to follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SQ | Change in Levels of Serum FSH | visit 4 | 0.2 miu/ml |
| SQ | Change in Levels of Serum FSH | visit 6 | 0.05 miu/ml |
| SQ | Change in Levels of Serum FSH | visit 5 | 0.1 miu/ml |
| SQ | Change in Levels of Serum FSH | visit 3 | NA miu/ml |
| SQ | Change in Levels of Serum FSH | visit 7 | 0.3 miu/ml |
| SQ | Change in Levels of Serum FSH | visit 2 | NA miu/ml |
| IM | Change in Levels of Serum FSH | visit 7 | NA miu/ml |
| IM | Change in Levels of Serum FSH | visit 2 | 1.3 miu/ml |
| IM | Change in Levels of Serum FSH | visit 3 | 0.4 miu/ml |
| IM | Change in Levels of Serum FSH | visit 4 | NA miu/ml |
| IM | Change in Levels of Serum FSH | visit 6 | NA miu/ml |
| IM | Change in Levels of Serum FSH | visit 5 | NA miu/ml |
Secondary
Change in Levels of Serum LH
Blood samples measured by Beckman assays and equipment.
Time frame: Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7
Population: loss to follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SQ | Change in Levels of Serum LH | visit 5 | 0.04 miu/ml |
| SQ | Change in Levels of Serum LH | visit 3 | NA miu/ml |
| SQ | Change in Levels of Serum LH | visit 6 | 0.1 miu/ml |
| SQ | Change in Levels of Serum LH | visit 2 | NA miu/ml |
| SQ | Change in Levels of Serum LH | visit 7 | 0.4 miu/ml |
| SQ | Change in Levels of Serum LH | visit 4 | 0.2 miu/ml |
| IM | Change in Levels of Serum LH | visit 7 | NA miu/ml |
| IM | Change in Levels of Serum LH | visit 4 | NA miu/ml |
| IM | Change in Levels of Serum LH | visit 5 | NA miu/ml |
| IM | Change in Levels of Serum LH | visit 2 | 0.4 miu/ml |
| IM | Change in Levels of Serum LH | visit 3 | 0.3 miu/ml |
| IM | Change in Levels of Serum LH | visit 6 | NA miu/ml |
Secondary
Change in Levels of Serum SHBG
Blood samples measured by Beckman assays and equipment.
Time frame: Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7
Population: loss to follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SQ | Change in Levels of Serum SHBG | visit 7 | 20.7 nmol/l |
| SQ | Change in Levels of Serum SHBG | visit 5 | 24.8 nmol/l |
| SQ | Change in Levels of Serum SHBG | visit 6 | 22.9 nmol/l |
| SQ | Change in Levels of Serum SHBG | visit 2 | NA nmol/l |
| SQ | Change in Levels of Serum SHBG | visit 3 | NA nmol/l |
| SQ | Change in Levels of Serum SHBG | visit 4 | 27.8 nmol/l |
| IM | Change in Levels of Serum SHBG | visit 3 | 22 nmol/l |
| IM | Change in Levels of Serum SHBG | visit 7 | NA nmol/l |
| IM | Change in Levels of Serum SHBG | visit 2 | 25.5 nmol/l |
| IM | Change in Levels of Serum SHBG | visit 5 | NA nmol/l |
| IM | Change in Levels of Serum SHBG | visit 4 | NA nmol/l |
| IM | Change in Levels of Serum SHBG | visit 6 | NA nmol/l |
Secondary
Change in Levels of Whole Blood Hematocrit
Blood samples measured by Quest assays and equipment.
Time frame: Last visit (Visit 7)
Population: loss to follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SQ | Change in Levels of Whole Blood Hematocrit | NA g/dL |
| IM | Change in Levels of Whole Blood Hematocrit | 1.9 g/dL |
Secondary
Change in Low Testosterone Questionnaire Responses
Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale is 1-5 (strongly disagree to strongly agree) Lower scores are better
Time frame: after last vist #7
Population: loss to follow up