Subcutaneous vs. Intramuscular Testosterone

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

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.

Study Overview

• Status: Completed
• Conditions: Hypogonadism, Male; Testosterone Deficiency
• Intervention / Treatment: Drug: Testosterone

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Men's Health Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SQ - IM; Subcutaneous testosterone injection followed by intramuscular testosterone injection	Drug: Testosterone; Testosterone cypionate injection; Other Names: Testosterone cypionate; Testosterone injection
Experimental: IM - SQ; Intramuscular testosterone injection followed by subcutaneous testosterone injection	Drug: Testosterone; Testosterone cypionate injection; Other Names: Testosterone cypionate; 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

Collaborators and Investigators

• Sponsor: Men's Health Boston
• Investigators: Principal Investigator: Abraham Morgentaler, MD, Men's Health Boston, Harvard Medical School

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): November 21, 2017
• Study Completion (Actual): January 2, 2018

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Eunuchism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: MHB023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No