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

NCT00467870 | Completed Phase 3 Results

• 1 other identifier: IP157-001
• Study Type: interventional
• Target: 531
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypogonadism; Primary Hypogonadism; Secondary Hypogonadism

Keywords

investigational; testosterone; testosterone undecanoate; TU; Hypogonadism; primary hypogonadism; secondary hypogonadism

Outcome Measures

Primary Outcomes (12)

• 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.

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

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

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

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

• 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

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

• 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

  Day 70 post injection at week 14

• 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.

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

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

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

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

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

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

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

• 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

  Day 70 post injection at week 24

• 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.

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

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

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

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

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

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

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

• 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

  Day 70 post injection at week 4

Secondary Outcomes (23)

• Serum Total Testosterone Maximum Concentration in Part A

  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

• Serum Total Testosterone Maximum Concentration in Part B

  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

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

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

• 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

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

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

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

Study Arms (2)

1

EXPERIMENTAL

750 mg dose of testosterone undecanoate

Drug: Testosterone Undecanoate 750 mg

2

EXPERIMENTAL

1000 mg dose testosterone undecanoate

Drug: Testosterone Undecanoate 1000 mg

Interventions

Testosterone Undecanoate 750 mg DRUG

1

Testosterone Undecanoate 1000 mg DRUG

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (1)

Indevus Pharmaceuticals, Inc.

Lexington, Massachusetts, 02421, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Indevus Pharmaceuticals, Inc.

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: May 1, 2007
• Study Start: March 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 5, 2017
• Results First Posted: March 7, 2017

Record last verified: 2017-09

Locations

US (1)