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Subcutaneous vs. Intramuscular Testosterone

Primary Purpose

Testosterone Deficiency, Hypogonadism, Male

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Testosterone

About this trial

This is an interventional treatment trial for Testosterone Deficiency

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Men's Health Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SQ - IM

IM - SQ

Arm Description

Subcutaneous testosterone injection followed by intramuscular testosterone injection

Intramuscular testosterone injection followed by subcutaneous testosterone injection

Outcomes

Primary Outcome Measures

Change in Levels of Serum Total Testosterone Concentration

Blood samples measured by Beckman assays and equipment.

Change in Levels of Serum Calculated Free T Concentration

Blood samples measured by Beckman assays and equipment.

Secondary Outcome Measures

Change in Levels of Serum Estradiol

Blood samples measured by Beckman assays and equipment.

Change in Levels of Serum LH

Blood samples measured by Beckman assays and equipment.

Change in Levels of Serum FSH

Blood samples measured by Beckman assays and equipment.

Change in Levels of Serum SHBG

Blood samples measured by Beckman assays and equipment.

Change in Level of Serum PSA

Blood samples measured by Beckman assays and equipment.

Change in Levels of Whole Blood Hematocrit

Blood samples measured by Quest assays and equipment.

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

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

Full Information

NCT ID

NCT03091348

First Posted

March 16, 2017

Last Updated

September 27, 2019

Sponsor

Men's Health Boston

1. Study Identification

Unique Protocol Identification Number

NCT03091348

Brief Title

Subcutaneous vs. Intramuscular Testosterone

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

August 29, 2017 (Actual)

Primary Completion Date

November 21, 2017 (Actual)

Study Completion Date

January 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Men's Health Boston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Testosterone Deficiency, Hypogonadism, Male

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SQ - IM

Arm Type

Experimental

Arm Description

Subcutaneous testosterone injection followed by intramuscular testosterone injection

Arm Title

IM - SQ

Arm Type

Experimental

Arm Description

Intramuscular testosterone injection followed by subcutaneous testosterone injection

Intervention Type

Drug

Intervention Name(s)

Testosterone

Other Intervention Name(s)

Testosterone cypionate, Testosterone injection

Intervention Description

Testosterone cypionate injection

Primary Outcome Measure Information:

Title

Change in Levels of Serum Total Testosterone Concentration

Description

Blood samples measured by Beckman assays and equipment.

Time Frame

"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Title

Change in Levels of Serum Calculated Free T Concentration

Description

Blood samples measured by Beckman assays and equipment.

Time Frame

"Last visit ( Visit 7)"

Secondary Outcome Measure Information:

Title

Change in Levels of Serum Estradiol

Description

Blood samples measured by Beckman assays and equipment.

Time Frame

"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Title

Change in Levels of Serum LH

Description

Blood samples measured by Beckman assays and equipment.

Time Frame

"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Title

Change in Levels of Serum FSH

Description

Blood samples measured by Beckman assays and equipment.

Time Frame

"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Title

Change in Levels of Serum SHBG

Description

Blood samples measured by Beckman assays and equipment.

Time Frame

"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Title

Change in Level of Serum PSA

Description

Blood samples measured by Beckman assays and equipment.

Time Frame

"Last visit (Visit 7)"

Title

Change in Levels of Whole Blood Hematocrit

Description

Blood samples measured by Quest assays and equipment.

Time Frame

"Last visit (Visit 7)"

Title

Change in Low Testosterone Questionnaire Responses

Description

Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale is 1-5 (strongly disagree to strongly agree) Lower scores are better

Time Frame

after last vist #7

Title

Change in International Prostate Symptom Scores

Description

Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale 0-35, from Mild to Severe Lower score is better

Time Frame

after last vist #7

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abraham Morgentaler, MD

Organizational Affiliation

Men's Health Boston, Harvard Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Men's Health Boston

City

Chestnut Hill

State/Province

Massachusetts

ZIP/Postal Code

02467

Country

United States

12. IPD Sharing Statement

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Subcutaneous vs. Intramuscular Testosterone

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