Subcutaneous vs. Intramuscular Testosterone
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/17/2018 |
| Start Date: | August 29, 2017 |
| End Date: | January 2, 2018 |
Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men
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.
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.
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
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