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

NCT ID: NCT00467870

Last Updated: 2017-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 531 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

750 mg dose of testosterone undecanoate

Group Type: EXPERIMENTAL

Testosterone Undecanoate 750 mg

Intervention Type: DRUG

2

1000 mg dose testosterone undecanoate

Group Type: EXPERIMENTAL

Testosterone Undecanoate 1000 mg

Intervention Type: DRUG

Interventions

Testosterone Undecanoate 750 mg

Intervention Type: DRUG

Testosterone Undecanoate 1000 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Indevus Pharmaceuticals, Inc.

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

Indevus Pharmaceuticals, Inc.

Lexington, Massachusetts, United States

Countries

United States

Other Identifiers

IP157-001

Identifier Type: -

Identifier Source: org_study_id