Subcutaneous vs. Intramuscular Testosterone

Hypogonadism, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091348
• Other study ID #: MHB023
• Status: Completed
• Phase: Phase 4
• Start date: August 29, 2017
• Est. completion date: January 2, 2018

Study information

• Verified date: September 2019
• Source: Men's Health Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 2, 2018
• Est. primary completion date: November 21, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male
• Testosterone Deficiency

Intervention

Drug:
• Testosterone
Testosterone cypionate injection

Locations

Country	Name	City	State
United States	Men's Health Boston	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Men's Health Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"
Primary	Change in Levels of Serum Calculated Free T Concentration	Blood samples measured by Beckman assays and equipment.	"Last visit ( Visit 7)"
Secondary	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"
Secondary	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"
Secondary	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"
Secondary	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"
Secondary	Change in Level of Serum PSA	Blood samples measured by Beckman assays and equipment.	"Last visit (Visit 7)"
Secondary	Change in Levels of Whole Blood Hematocrit	Blood samples measured by Quest assays and equipment.	"Last visit (Visit 7)"
Secondary	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
Secondary	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