Subcutaneous vs. Intramuscular Testosterone

Phase 4

Completed

• Conditions: Testosterone Deficiency; Hypogonadism, Male
• Interventions: Drug: Testosterone

• Registration Number: NCT03091348
• Lead Sponsor: Men's Health Boston

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.

Study Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Study Start: 2017-08-29
• Primary Completion: 2017-11-21
• Study Completion: 2018-01-02
• Results First Submitted: 2019-01-14
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-04
• Results First Posted: 2019-09-25
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SQ - IM	Testosterone	Subcutaneous testosterone injection followed by intramuscular testosterone injection
IM - SQ	Testosterone	Intramuscular testosterone injection followed by subcutaneous testosterone injection

Primary Outcome Measures

Name	Time	Method
Change in Levels of Serum Total Testosterone Concentration	"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"	Blood samples measured by Beckman assays and equipment.
Change in Levels of Serum Calculated Free T Concentration	"Last visit ( Visit 7)"	Blood samples measured by Beckman assays and equipment.

Secondary Outcome Measures

Name	Time	Method
Change in Levels of Serum Estradiol	"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"	Blood samples measured by Beckman assays and equipment.
Change in Levels of Serum LH	"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"	Blood samples measured by Beckman assays and equipment.
Change in Levels of Serum FSH	"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"	Blood samples measured by Beckman assays and equipment.
Change in Levels of Serum SHBG	"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"	Blood samples measured by Beckman assays and equipment.
Change in Level of Serum PSA	"Last visit (Visit 7)"	Blood samples measured by Beckman assays and equipment.
Change in Levels of Whole Blood Hematocrit	"Last visit (Visit 7)"	Blood samples measured by Quest assays and equipment.
Change in Low Testosterone Questionnaire Responses	after last vist #7	Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale is 1-5 (strongly disagree to strongly agree) Lower scores are better
Change in International Prostate Symptom Scores	after last vist #7	Answers recorded at baseline, 2 weeks, up to 4 weeks.; Scale 0-35, from Mild to Severe Lower score is better

Trial Locations

Locations (1)

Men's Health Boston; 🇺🇸 Chestnut Hill, Massachusetts, United States