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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03091348
Other study ID # MHB023
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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