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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SQ - IM | Experimental | Subcutaneous testosterone injection followed by intramuscular testosterone injection |
|
| IM - SQ | Experimental | Intramuscular testosterone injection followed by subcutaneous testosterone injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Testosterone cypionate injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Levels of Serum Total Testosterone Concentration | Blood samples measured by Beckman assays and equipment. | "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7" |
| Change in Levels of Serum Calculated Free T Concentration | Blood samples measured by Beckman assays and equipment. | "Last visit ( Visit 7)" |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Levels of Serum Estradiol | Blood samples measured by Beckman assays and equipment. | "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7" |
| Change in Levels of Serum LH | Blood samples measured by Beckman assays and equipment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abraham Morgentaler, MD | Men's Health Boston, Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Men's Health Boston | Chestnut Hill | Massachusetts | 02467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SQ - IM | Subcutaneous testosterone injection followed by intramuscular testosterone injection Testosterone: Testosterone cypionate injection |
| FG001 | IM - SQ | Intramuscular testosterone injection followed by subcutaneous testosterone injection Testosterone: Testosterone cypionate injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants analyzed is 0 and 1 due to loss to follow up
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| ID | Title | Description |
|---|---|---|
| BG000 | SQ-IM | Subcutaneous testosterone injection followed by intramuscular testosterone injection Testosterone: Testosterone cypionate injection |
| BG001 | IM-SQ | Intramuscular testosterone injection followed by subcutaneous testosterone injection Testosterone: Testosterone cypionate injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | loss to follow up |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Levels of Serum Total Testosterone Concentration | Blood samples measured by Beckman assays and equipment. | loss to follow up | Posted | Number | ng/dl | "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7" |
|
AE were monitored/assessed at each study visit.
An adverse event is defined as any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Include the type and duration of the follow-up of subjects after adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SQ Testosterone | Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abraham Morgentaler | Men | 617-277-5000 | research@menshealthboston.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2017 | Jan 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005058 | Eunuchism |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| C016131 | testosterone 17 beta-cypionate |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7" |
| Change in Levels of Serum FSH | Blood samples measured by Beckman assays and equipment. | "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7" |
| Change in Levels of Serum SHBG | Blood samples measured by Beckman assays and equipment. | "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7" |
| Change in Level of Serum PSA | Blood samples measured by Beckman assays and equipment. | "Last visit (Visit 7)" |
| Change in Levels of Whole Blood Hematocrit | Blood samples measured by Quest assays and equipment. | "Last visit (Visit 7)" |
| 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 | after last vist #7 |
| 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 | after last vist #7 |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | loss to follow up caused only 1 subject to be analyzed | Count of Participants | Participants |
|
| Race (NIH/OMB) | loss to follow up | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Estradiol (E2) | loss to follow up | Number | pg/ml |
|
| Human Follicle Stimulating Hormone (hFSH) | loss to follow up | Number | miu/ml |
|
| Hemophagocytic lymphohistiocytosis(hLH) | loss to follow up | Number | miu/ml |
|
| Sex hormone binding globulin(SHBG) | loss to follow up | Number | nmol/l |
|
| Testosterone | loss to follow up | Number | ng/dl |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Change in Levels of Serum Calculated Free T Concentration | Blood samples measured by Beckman assays and equipment. | loss to follow up | Posted | Number | ng/dL | "Last visit ( Visit 7)" |
|
|
|
| Secondary | Change in Levels of Serum Estradiol | Blood samples measured by Beckman assays and equipment. | loss to follow up | Posted | Number | pg/mL | "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7" |
|
|
|
| Secondary | Change in Levels of Serum LH | Blood samples measured by Beckman assays and equipment. | loss to follow up | Posted | Number | miu/ml | "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7" |
|
|
|
| Secondary | Change in Levels of Serum FSH | Blood samples measured by Beckman assays and equipment. | loss to follow up | Posted | Number | miu/ml | "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7" |
|
|
|
| Secondary | Change in Levels of Serum SHBG | Blood samples measured by Beckman assays and equipment. | loss to follow up | Posted | Number | nmol/l | "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7" |
|
|
|
| Secondary | Change in Level of Serum PSA | Blood samples measured by Beckman assays and equipment. | loss to follow up | Posted | Number | ng/mL | "Last visit (Visit 7)" |
|
|
|
| Secondary | Change in Levels of Whole Blood Hematocrit | Blood samples measured by Quest assays and equipment. | loss to follow up | Posted | Number | g/dL | "Last visit (Visit 7)" |
|
|
|
| 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 | loss to follow up | Posted | after last vist #7 |
|
|
| 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 | loss to follow up | Posted | after last vist #7 |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | IM Testosterone | Intramuscular testosterone injection Testosterone: Testosterone cypionate injection | 0 | 2 | 0 | 2 | 0 | 2 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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