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

Endo Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Secondary Hypogonadism

Primary Hypogonadism

Hypogonadism

Treatments

Drug: Testosterone Undecanoate 750 mg

Drug: Testosterone Undecanoate 1000 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00467870

IP157-001

Details and patient eligibility

About

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

Enrollment

531 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)