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Completed

NCT Number: NCT03091348

Subcutaneous vs. Intramuscular Testosterone

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.

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Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Men's Health Boston

Chestnut Hill, Massachusetts, 02467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone

Drug

Testosterone cypionate injection

Other names: Testosterone cypionate, Testosterone injection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Men's Health Boston

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 27, 2017
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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