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Subcutaneous vs. Intramuscular Testosterone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091348
Recruitment Status : Completed
First Posted : March 27, 2017
Results First Posted : September 25, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Abraham Morgentaler, Men's Health Boston

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : August 29, 2017
Actual Primary Completion Date : November 21, 2017
Actual Study Completion Date : January 2, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in Levels of Serum Total Testosterone Concentration [ Time Frame: "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 [ Time Frame: "Last visit ( Visit 7)" ]
    Blood samples measured by Beckman assays and equipment.


Secondary Outcome Measures :
  1. Change in Levels of Serum Estradiol [ Time Frame: "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 [ Time Frame: "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 [ Time Frame: "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 [ Time Frame: "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 [ Time Frame: "Last visit (Visit 7)" ]
    Blood samples measured by Beckman assays and equipment.

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

  7. Change in Low Testosterone Questionnaire Responses [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091348


Locations
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United States, Massachusetts
Men's Health Boston
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Men's Health Boston
Investigators
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Principal Investigator: Abraham Morgentaler, MD Men's Health Boston, Harvard Medical School
  Study Documents (Full-Text)

Documents provided by Dr. Abraham Morgentaler, Men's Health Boston:
Study Protocol and Statistical Analysis Plan  [PDF] February 23, 2017

More Information
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Responsible Party: Dr. Abraham Morgentaler, Director, Men's Health Boston
ClinicalTrials.gov Identifier: NCT03091348    
Other Study ID Numbers: MHB023
First Posted: March 27, 2017    Key Record Dates
Results First Posted: September 25, 2019
Last Update Posted: October 8, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
 Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents