Long-Term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
Information source: Indevus Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism; Primary Hypogonadism; Secondary Hypogonadism
Intervention: Testosterone Undecanoate (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Indevus Pharmaceuticals Official(s) and/or principal investigator(s):
Indevus Pharmaceuticals, Inc., Study Director, Affiliation: Sponsor
Summary
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: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Ending date: July 2009
Last updated: January 17, 2008
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