Subcutaneous vs. Intramuscular Testosterone
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ClinicalTrials.gov Identifier: NCT03091348 |
Recruitment Status :
Completed
First Posted : March 27, 2017
Results First Posted : September 25, 2019
Last Update Posted : October 8, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Testosterone Deficiency Hypogonadism, Male | Drug: Testosterone | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men |
Actual Study Start Date : | August 29, 2017 |
Actual Primary Completion Date : | November 21, 2017 |
Actual Study Completion Date : | January 2, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: SQ - IM
Subcutaneous testosterone injection followed by intramuscular testosterone injection
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Drug: Testosterone
Testosterone cypionate injection
Other Names:
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Experimental: IM - SQ
Intramuscular testosterone injection followed by subcutaneous testosterone injection
|
Drug: Testosterone
Testosterone cypionate injection
Other Names:
|
- Change in Levels of Serum Total Testosterone Concentration [ Time Frame: "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 [ Time Frame: "Last visit ( Visit 7)" ]Blood samples measured by Beckman assays and equipment.
- Change in Levels of Serum Estradiol [ Time Frame: "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 LH [ Time Frame: "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 FSH [ Time Frame: "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 [ Time Frame: "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 [ Time Frame: "Last visit (Visit 7)" ]Blood samples measured by Beckman assays and equipment.
- Change in Levels of Whole Blood Hematocrit [ Time Frame: "Last visit (Visit 7)" ]Blood samples measured by Quest assays and equipment.
- Change in Low Testosterone Questionnaire Responses [ Time Frame: 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 [ Time Frame: 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091348
United States, Massachusetts | |
Men's Health Boston | |
Chestnut Hill, Massachusetts, United States, 02467 |
Principal Investigator: | Abraham Morgentaler, MD | Men's Health Boston, Harvard Medical School |
Documents provided by Dr. Abraham Morgentaler, Men's Health Boston:
Responsible Party: | Dr. Abraham Morgentaler, Director, Men's Health Boston |
ClinicalTrials.gov Identifier: | NCT03091348 |
Other Study ID Numbers: |
MHB023 |
First Posted: | March 27, 2017 Key Record Dates |
Results First Posted: | September 25, 2019 |
Last Update Posted: | October 8, 2019 |
Last Verified: | September 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hypogonadism Eunuchism Gonadal Disorders Endocrine System Diseases Methyltestosterone Testosterone Testosterone undecanoate Testosterone enanthate |
Testosterone 17 beta-cypionate Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |