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HypogonadismPhase 3TUNCT00467870

Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men

A Phase 3 study testing Testosterone Undecanoate 750 mg and Testosterone Undecanoate 1000 mg in people with Hypogonadism and Primary Hypogonadism, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Testosterone Undecanoate 750 mg and Testosterone Undecanoate 1000 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
531 participants
Where
1 siteUnited States
Study dates
Mar 2006to Jul 2009
Phase
Phase 3
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male with primary or secondary hypogonadism at least 18 years of age and for study part C2 weighs ≥143.3 lb (≥65 kg)
  • Morning screening serum testosterone concentration <300 ng/dL

Who cannot join

  • American Urological Association (AUA) Symptom Score ≥15 or significant prostatic symptoms
  • History of carcinoma, tumors or induration of the prostate or the male mammary gland including suspicion thereof
  • Screening serum prostate-specific antigen (PSA) level >4 ng/mL or hyperplasia of the prostate (size >75 cm3 as measured by transrectal ultrasonography)
  • Past or present liver tumors or acute or chronic hepatic disease with impairment of liver function; liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) exceeding 1.5 times upper limit of normal
  • History of deep vein thrombosis in the past 5 years or any history of cerebrovascular accident
  • Severe acne
Show all 13Show fewer
  • Hypertension (systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm Hg) or coronary heart disease not stabilized by therapy as assessed by the investigator
  • Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C) level is >9%
  • Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7 days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit and throughout the study (exclusive of administered study drug)
  • Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone [DHEA]) by any application method within the 28 days prior to first administration of study drug and throughout the study (exclusive of administrated study drug)
  • Medication with substances which might interfere with testosterone metabolism within 28 days before the first administration of study drug
  • History of sleep apnea Insulin-dependent diabetes mellitus
  • Use of steroidal anabolic drugs or supplements by any application method within the 28-days prior to the first administration of the study drug and throughout the study (exclusive of the administered study drug)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indevus Pharmaceuticals, Inc.

    Lexington, Massachusetts, 02421

Other trials in United States

About this study

Official title: A Two-Arm, Open-Label, Randomized, Multi-Center Pharmacokinetic and Long-Term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men

To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.

Being tested
Testosterone Undecanoate 750 mg, Testosterone Undecanoate 1000 mg
Keywords
investigational, testosterone, testosterone undecanoate, TU, Hypogonadism, primary hypogonadism, secondary hypogonadism
Medical subject headings
Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testosterone Undecanoate 750 mgDrug

  • Testosterone Undecanoate 1000 mgDrug

Study groups in NCT00467870
Study groupRoleWhat they receive
1Experimental750 mg dose of testosterone undecanoate
Receives: Drug: Testosterone Undecanoate 750 mg
2Experimental1000 mg dose testosterone undecanoate
Receives: Drug: Testosterone Undecanoate 1000 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C

    Responders were participants with serum total testosterone average concentration (Cavg) between 300 and 1000 ng/dL derived from the 3rd injection intensive pharmacokinetic (IPK) interval.

    Measured: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

  2. Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C

    Serum total testosterone Cavg derived from the 3rd injection IPK interval

    Measured: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

  3. Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C

    Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval

    Measured: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

  4. Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C

    Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval

    Measured: Day 70 post injection at week 14

  5. Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C

    Responders were participants with serum total testosterone Cavg between 300 and 1000 ng/dL derived from the 4th injection IPK interval.

    Measured: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

  6. Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C

    Serum total testosterone Cavg derived from the 4th injection IPK interval

    Measured: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

  7. Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C

    Serum total testosterone Cmax derived from the 4th injection IPK interval

    Measured: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

  8. Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C

    Serum total testosterone Ctrough derived from the 4th injection IPK interval

    Measured: Day 70 post injection at week 24

  9. Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2

    Success was defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.

    Measured: Days 0, 4, 7, 11, 14, and 70 post injection at week 4

  10. Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2

    Serum total testosterone Cavg derived from the 2nd injection IPK interval

    Measured: Days 0, 4, 7, 11, 14, and 70 post injection at week 4

  11. Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2

    Serum total testosterone Cmax derived from the 2nd injection IPK interval

    Measured: Days 0, 4, 7, 11, 14, and 70 post injection at week 4

  12. Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2

    Serum total testosterone Ctrough derived from the 2nd injection IPK interval

    Measured: Day 70 post injection at week 4

Secondary outcomes (23)

  1. Serum Total Testosterone Maximum Concentration in Part A

    Measured: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 1, week 12, week 24, and week 36; and post injection at weeks 48, 60, 72, 84, 96, 108, and 120

  2. Serum Total Testosterone Maximum Concentration in Part B

    Measured: Post injection at week 1; post injection at week 8; days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 20; and post injection at weeks 32, 44, 56, 68, and 80

  3. Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C

    Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.

    Measured: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

  4. Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C

    Measured: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

  5. Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C

    Measured: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

  6. Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C

    Measured: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

  7. Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C

    Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL

    Measured: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

  8. Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C

    Measured: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

  9. Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C

    Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.

    Measured: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

  10. Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C

    Measured: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

  11. Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C

    Measured: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

  12. Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C

    Measured: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

  13. Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C

    Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL

    Measured: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

  14. Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C

    Measured: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

  15. Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C

    M-PGA is a 5-item self-report questionnaire to assess perception of change from pretreatment or baseline in hypogonadal symptoms including confidence/self-esteem, sexual performance, moods/behavior, overall feeling of well-being, and satisfaction with study treatment rated on a 7-point scale where items 1-4 were rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse) and item 5 was rated as 1 (very much satisfied), 2 (much satisfied), 3 (minimally satisfied), 4 (neither satisfied nor dissatisfied), 5 (minimally dissatisfied), 6 (much dissatisfied), 7 (very much dissatisfied). Collapsed ratings: Improved=Very much, much, or minimally improved; Worsened=Very much, much, or minimally worse; No change; Satisfied=Very much, much, or minimally satisfied; Not satisfied=Very much, much, or minimally dissatisfied; No opinion (neither satisfied nor dissatisfied).

    Measured: Day 21 post injection at week 14

  16. Change in Body Mass Index From Baseline to Week 24 in Part C

    Difference in Body Mass Index (BMI) from baseline to week 24 calculated from weight (kg) divided by height squared (m2)

    Measured: Baseline, Week 24

  17. Change in Weight From Baseline to Week 24 in Part C

    Measured: Baseline, Week 24

  18. Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2

    Measured: Days 0, 4, 7, 11, 14, and 70 post injection at week 4

  19. Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2

    Measured: Days 0, 4, 7, 11, 14, and 70 post injection at week 4

  20. Serum Total Testosterone Concentrations in Part C2

    Measured: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44

  21. Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2

    Serum total testosterone concentrations outside the normal range are categorized as <300 ng/dL (below lower limit of normal range) and >1000 ng/dL (above upper limit of normal range)

    Measured: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44

  22. Trough Assessments of Serum Total Testosterone Concentrations in Part C2

    Measured: Screening; day 0; and weeks 4, 14, 24, 34, and 44

  23. Serum Total Testosterone Maximum Concentration in Part C2

    Measured: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; and weeks 14, 24, 34, and 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2007 (estimated)
  2. Study startMar 2006
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
531 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00467870
Sponsor's protocol ID
IP157-001
Acronym
TU
Status last verified
Sep 2017
First submitted
27 Apr 2007
Last updated
5 Oct 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Testosterone Undecanoate 750 mg and Testosterone Undecanoate 1000 mg in people with Hypogonadism and Primary Hypogonadism, run by Endo USA Inc., a Keenova Therapeutics Company 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 2 inclusion and 13 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 5 Oct 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Mar 2017). 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?

Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C (time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00467870.

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 5 Oct 2017.

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