Testosterone DeficiencyPhase 4NCT03091348
Subcutaneous vs. Intramuscular Testosterone
A Phase 4 study testing Testosterone in people with Testosterone Deficiency and Hypogonadism, Male, run by Men's Health Boston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Testosterone Deficiency, Hypogonadism, Male
- What is being tested?
- Testosterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2017to 2 Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Men's Health Boston
Chestnut Hill, Massachusetts, 02467
About this study
Official title: Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men
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.
Read the detailed 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.
- Conditions
- Testosterone Deficiency, Hypogonadism, Male
- Being tested
- Testosterone
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called Testosterone cypionate, Testosterone injection
Testosterone cypionate injection
| Study group | Role | What they receive |
|---|---|---|
| SQ - IM | Experimental | Subcutaneous testosterone injection followed by intramuscular testosterone injection Receives: Drug: Testosterone |
| IM - SQ | Experimental | Intramuscular testosterone injection followed by subcutaneous testosterone injection Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Levels of Serum Total Testosterone Concentration
Blood samples measured by Beckman assays and equipment.
Measured: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Change in Levels of Serum Calculated Free T Concentration
Blood samples measured by Beckman assays and equipment.
Measured: "Last visit ( Visit 7)"
Secondary outcomes (8)
Change in Levels of Serum Estradiol
Blood samples measured by Beckman assays and equipment.
Measured: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Change in Levels of Serum LH
Blood samples measured by Beckman assays and equipment.
Measured: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Change in Levels of Serum FSH
Blood samples measured by Beckman assays and equipment.
Measured: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Change in Levels of Serum SHBG
Blood samples measured by Beckman assays and equipment.
Measured: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Change in Level of Serum PSA
Blood samples measured by Beckman assays and equipment.
Measured: "Last visit (Visit 7)"
Change in Levels of Whole Blood Hematocrit
Blood samples measured by Quest assays and equipment.
Measured: "Last visit (Visit 7)"
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
Measured: after last vist #7
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
Measured: after last vist #7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start29 Aug 2017
- Primary completion21 Nov 2017
- Study completion2 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Testosterone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Men's Health Boston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Abraham Morgentaler, Men's Health Boston
- Investigators
- Abraham Morgentaler, MD, Principal investigator, Men's Health Boston, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091348
- Sponsor's protocol ID
- MHB023
- Status last verified
- Sep 2019
- First submitted
- 16 Mar 2017
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men
- ClinicalTrials.gov ID
- NCT03091348
- Acronym / sponsor ID
- MHB023
- Conditions
- Testosterone Deficiency, Hypogonadism, Male
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Men's Health BostonUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SQ - IM | Experimental | Drug: TestosteroneSubcutaneous testosterone injection followed by intramuscular testosterone injection |
| IM - SQ | Experimental | Drug: TestosteroneIntramuscular testosterone injection followed by subcutaneous testosterone injection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneAlso: Testosterone cypionate, Testosterone injectionTestosterone cypionate injection | Drug | IM - SQ, SQ - IM |
Primary outcome
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.
Change in Levels of Serum Calculated Free T Concentration
Time frame: "Last visit ( Visit 7)"
Blood samples measured by Beckman assays and equipment.
8 secondary outcomes
Change in Levels of Serum Estradiol
Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Change in Levels of Serum LH
Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Change in Levels of Serum FSH
Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Change in Levels of Serum SHBG
Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Change in Level of Serum PSA
Time frame: "Last visit (Visit 7)"
Change in Levels of Whole Blood Hematocrit
Time frame: "Last visit (Visit 7)"
Change in Low Testosterone Questionnaire Responses
Time frame: after last vist #7
Change in International Prostate Symptom Scores
Time frame: after last vist #7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Testosterone Deficiency
Not yet recruiting
Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause
Menopause, Sexual Dysfunction
Enrolling by invitation
AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
Hypogonadism, Male, Secondary Hypogonadism
RecruitingPhase 2
High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
Metastatic Prostate Cancer
RecruitingObservational study
Anthropometric, Functional and Lifestyle Factors Associated With Testosterone Levels in Middle-Aged Men
Testosterone Deficiency, Male Hypogonadism
Active, not recruitingPhase 2
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Hypogonadism, Male, Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Morgentaler, MD principal investigator
Men's Health Boston, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone in people with Testosterone Deficiency and Hypogonadism, Male, run by Men's Health Boston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Levels of Serum Total Testosterone Concentration (time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.