Clinical trial NCT03091348: Subcutaneous vs. Intramuscular Testosterone
Official title: Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Testosterone Deficiency
Hypogonadism, Male
Lead sponsor: Men's Health Boston
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 4
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Levels of Serum Total Testosterone Concentration
timeFrame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
measure: Change in Levels of Serum Calculated Free T Concentration
timeFrame: "Last visit ( Visit 7)"
Secondary outcomes:
measure: Change in Levels of Serum Estradiol
timeFrame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
measure: Change in Levels of Serum LH
timeFrame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
measure: Change in Levels of Serum FSH
timeFrame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
measure: Change in Levels of Serum SHBG
timeFrame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
measure: Change in Level of Serum PSA
timeFrame: "Last visit (Visit 7)"
measure: Change in Levels of Whole Blood Hematocrit
timeFrame: "Last visit (Visit 7)"
measure: Change in Low Testosterone Questionnaire Responses
timeFrame: after last vist #7
measure: Change in International Prostate Symptom Scores
timeFrame: after last vist #7
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Men's Health Boston
state: Massachusetts
Study officials:
affiliation: Men's Health Boston, Harvard Medical School
name: Abraham Morgentaler, MD
role: PRINCIPAL_INVESTIGATOR
References: