Subcutaneous vs. Intramuscular Testosterone

Men's Health Boston

Status and phase

Completed

Phase 4

Conditions

Testosterone Deficiency

Hypogonadism, Male

Treatments

Drug: Testosterone

Study type

Interventional

Funder types

Other

Identifiers

NCT03091348

MHB023

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

Male

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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