Status:
COMPLETED
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Hypogonadism
Primary Hypogonadism
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT00467870
Start Date
March 1 2006
End Date
July 1 2009
Last Update
October 5 2017
Active Locations (1)
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1
Indevus Pharmaceuticals, Inc.
Lexington, Massachusetts, United States, 02421