Subcutaneous vs. Intramuscular Testosterone

Study Overview
=================
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.

Official Title
-----------------
Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men

Conditions
-----------------
Testosterone Deficiency, Hypogonadism, Male

Intervention / Treatment
-----------------
* Drug: Testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SQ - IM<br>Subcutaneous testosterone injection followed by intramuscular testosterone injection | Drug: Testosterone<br>* Testosterone cypionate injection<br>* Other names: Testosterone injection;|
| Experimental: IM - SQ<br>Intramuscular testosterone injection followed by subcutaneous testosterone injection | Drug: Testosterone<br>* Testosterone cypionate injection<br>* Other names: Testosterone injection;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |