Clinical Trial: Subcutaneous vs. Intramuscular Testosterone

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men

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.

Detailed Summary:
Sponsor: Men's Health Boston

Current Primary Outcome:

  • Change in levels of serum total testosterone concentration [ Time Frame: 4 weeks ]
    Blood samples measured by Beckman assays and equipment.
  • Change in levels of serum calculated free T concentration [ Time Frame: 4 weeks ]
    Blood samples measured by Beckman assays and equipment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in levels of serum estradiol [ Time Frame: 4 weeks ]
    Blood samples measured by Beckman assays and equipment.
  • Change in levels of serum LH [ Time Frame: 4 weeks ]
    Blood samples measured by Beckman assays and equipment.
  • Change in levels of serum FSH [ Time Frame: 4 weeks ]
    Blood samples measured by Beckman assays and equipment.
  • Change in levels of serum SHBG [ Time Frame: 4 weeks ]
    Blood samples measured by Beckman assays and equipment.
  • Change in level of serum PSA [ Time Frame: 4 weeks ]
    Blood samples measured by Beckman assays and equipment.
  • Change in levels of whole blood hematocrit [ Time Frame: 4 weeks ]
    Blood samples measured by Quest assays and equipment.
  • Change in Low Testosterone Questionnaire responses [ Time Frame: 4 weeks ]
    Answers recorded at baseline, 2 weeks, 4 weeks.
  • Change in International Prostate Symptom Scores [ Time Frame: 4 weeks ]
    Answers recorded at baseline, 2 weeks, 4 weeks.


Original Secondary Outcome: Same as current

Information By: Men's Health Boston

Dates:
Date Received: March 16, 2017
Date Started: March 2017
Date Completion: September 2018
Last Updated: March 21, 2017
Last Verified: March 2017