Men's Health Boston
Chestnut Hill, Massachusetts, 02467, United States
NCT Number: NCT03091348
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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Notify Me18 year–90 year
Male
Interventional
Phase 4
Chestnut Hill, Massachusetts, 02467, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Testosterone cypionate injection
Other names: Testosterone cypionate, Testosterone injection
Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Blood samples measured by Beckman assays and equipment.
Time frame: "Last visit ( Visit 7)"
Blood samples measured by Beckman assays and equipment.
Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Blood samples measured by Beckman assays and equipment.
Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Blood samples measured by Beckman assays and equipment.
Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Blood samples measured by Beckman assays and equipment.
Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Blood samples measured by Beckman assays and equipment.
Time frame: "Last visit (Visit 7)"
Blood samples measured by Beckman assays and equipment.
Time frame: "Last visit (Visit 7)"
Blood samples measured by Quest assays and equipment.
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
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
Men's Health Boston
Other
Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men
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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