NCT03091348

Subcutaneous vs. Intramuscular Testosterone

Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Men's Health Boston · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Testosterone Deficiency
• Hypogonadism, Male

Interventions

Type	Name	Description
DRUG	Testosterone	Testosterone cypionate injection

Timeline

• Start date: 2017-08-29
• Primary completion: 2017-11-21
• Completion: 2018-01-02
• First posted: 2017-03-27
• Last updated: 2019-10-08
• Results posted: 2019-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study