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

Information source: Endo Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism; Primary Hypogonadism; Secondary Hypogonadism

Intervention: Testosterone Undecanoate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Endo Pharmaceuticals

Official(s) and/or principal investigator(s):
Indevus Pharmaceuticals, Inc., Study Director, Affiliation: Sponsor GmbH


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To evaluate the pharmacokinetics of TU

Secondary outcome: To compare serum levels of DHT, E2, and SHBG to simultaneous levels of serum total testosterone at steady state


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


Inclusion Criteria:

- Male with primary or secondary hypogonadism at least 18 years of age

- Morning screening serum testosterone concentration < 300 ng/dL

Exclusion Criteria:

- History of carcinoma, tumors or induration of the prostate or the male

mammary gland including suspicion thereof

- 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)

Locations and Contacts

Indevus Pharmaceuticals, Inc., Lexington, Massachusetts 02421, United States
Additional Information

Starting date: March 2006
Last updated: September 13, 2012

Page last updated: August 23, 2015

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