Subcutaneous vs. Intramuscular Testosterone

• Sponsor: Men's Health Boston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03091348
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.1
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Testosterone Deficiency; Hypogonadism, Male	Drug: Testosterone	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men
• Actual Study Start Date: Aug 29, 2017
• Actual Primary Completion Date: Nov 21, 2017
• Actual Study Completion Date: Jan 2, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. Change in Levels of Serum Calculated Free T Concentration ["Last visit ( Visit 7)"]

   Blood samples measured by Beckman assays and equipment.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. Change in Level of Serum PSA ["Last visit (Visit 7)"]

   Blood samples measured by Beckman assays and equipment.

6. Change in Levels of Whole Blood Hematocrit ["Last visit (Visit 7)"]

   Blood samples measured by Quest assays and equipment.

7. 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

8. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Men's Health Boston	Chestnut Hill	Massachusetts	United States	02467

Sponsors and Collaborators

• Men's Health Boston

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 23, 2017

More Information

Publications

None provided.

• Responsible Party: Dr. Abraham Morgentaler, Director, Men's Health Boston
• ClinicalTrials.gov Identifier: NCT03091348
• Other Study ID Numbers: MHB023
• First Posted: Mar 27, 2017
• Last Update Posted: Oct 8, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypogonadism; Eunuchism; Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate

Study Results

Participant Flow

Arm/Group Title	SQ - IM	IM - SQ
Arm/Group Description	Subcutaneous testosterone injection followed by intramuscular testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection followed by subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
Period Title: Overall Study
STARTED	2	2
COMPLETED	0	1
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	SQ-IM	IM-SQ	Total
Arm/Group Description	Subcutaneous testosterone injection followed by intramuscular testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection followed by subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Total of all reporting groups
Overall Participants	0	1	1
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44 (0)	44 (0)
Sex: Female, Male (Count of Participants)
Female	0 NaN	0 0%	0 0%
Male	0 NaN	1 100%	1 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 NaN	0 0%
Asian	0 NaN	0 0%
Native Hawaiian or Other Pacific Islander	0 NaN	0 0%
Black or African American	0 NaN	0 0%
White	1 Infinity	1 100%
More than one race	0 NaN	0 0%
Unknown or Not Reported	0 NaN	0 0%
Region of Enrollment (participants) [Number]
United States	1 Infinity	1 100%
Estradiol (E2) (pg/ml) [Number]
Number [pg/ml]	24.5	24.5
Human Follicle Stimulating Hormone (hFSH) (miu/ml) [Number]
Number [miu/ml]	3.5	3.5
Hemophagocytic lymphohistiocytosis(hLH) (miu/ml) [Number]
Number [miu/ml]	3	3
Sex hormone binding globulin(SHBG) (nmol/l) [Number]
Number [nmol/l]	27.3	27.3
Testosterone (ng/dl) [Number]
Number [ng/dl]	317.1	317.1

Outcome Measures

1. Primary Outcome

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"

Outcome Measure Data

Analysis Population Description

loss to follow up

Arm/Group Title	"SQ"	"IM"
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
Measure Participants	1	1
visit 2	NA	1043.6
visit 3	NA	785.7
visit 4	203.5	NA
vist 5	1367.9	NA
visit 6	980.8	NA
visit 7	144.7	NA

2. Primary Outcome

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)"

Outcome Measure Data

Analysis Population Description

loss to follow up

Arm/Group Title	"SQ"	"IM"
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
Measure Participants	1	1
Number [ng/dL]	0.84	14.74

3. Secondary Outcome

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"

Outcome Measure Data

Analysis Population Description

loss to follow up

Arm/Group Title	"SQ"	"IM"
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
Measure Participants	1	1
visit 2	NA	70.03
visit 3	NA	52.00
visit 4	30.06	NA
visit 5	45.12	NA
visit 6	64.74	NA
visit 7	25.99	NA

4. Secondary Outcome

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"

Outcome Measure Data

Analysis Population Description

loss to follow up

Arm/Group Title	"SQ"	"IM"
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection Testosterone : Testosterone cypionate injection
Measure Participants	1	1
visit 2	NA	0.4
visit 3	NA	0.3
visit 4	0.2	NA
visit 5	0.04	NA
visit 6	0.1	NA
visit 7	0.4	NA

5. Secondary Outcome

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"

Outcome Measure Data

Analysis Population Description

loss to follow up

Arm/Group Title	"SQ"	"IM"
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
Measure Participants	1	1
visit 2	NA	1.3
visit 3	NA	0.4
visit 4	0.2	NA
visit 5	0.1	NA
visit 6	0.05	NA
visit 7	0.3	NA

6. Secondary Outcome

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"

Outcome Measure Data

Analysis Population Description

loss to follow up

Arm/Group Title	"SQ"	"IM"
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
Measure Participants	1	1
visit 2	NA	25.5
visit 3	NA	22
visit 4	27.8	NA
visit 5	24.8	NA
visit 6	22.9	NA
visit 7	20.7	NA

7. Secondary Outcome

Title	Change in Level of Serum PSA
Description	Blood samples measured by Beckman assays and equipment.
Time Frame	"Last visit (Visit 7)"

Outcome Measure Data

Analysis Population Description

loss to follow up

Arm/Group Title	"SQ"	"IM"
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
Measure Participants	1	1
Number [ng/mL]	0.25	0.02

8. Secondary Outcome

Title	Change in Levels of Whole Blood Hematocrit
Description	Blood samples measured by Quest assays and equipment.
Time Frame	"Last visit (Visit 7)"

Outcome Measure Data

Analysis Population Description

loss to follow up

Arm/Group Title	"SQ"	"IM"
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
Measure Participants	1	1
Number [g/dL]	NA	1.9

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

loss to follow up

Arm/Group Title	"SQ"	"IM"
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
Measure Participants	0	0

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

loss to follow up

Arm/Group Title	"SQ"	"IM"
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection	Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
Measure Participants	0	0

Adverse Events

Time Frame	AE were monitored/assessed at each study visit.
Adverse Event Reporting Description	An adverse event is defined as any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Include the type and duration of the follow-up of subjects after adverse events.
Arm/Group Title	SQ Testosterone		IM Testosterone
Arm/Group Description	Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection		Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
All Cause Mortality
	SQ Testosterone		IM Testosterone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Serious Adverse Events
	SQ Testosterone		IM Testosterone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	SQ Testosterone		IM Testosterone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.