Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:5/5/2014
Start Date:February 2014
End Date:December 2015

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Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men

The purpose of this study is to determine the safety and efficacy of an oral testosterone
undecanoate formulation for use as testosterone-replacement therapy in men with low
testosterone.


Inclusion Criteria:

1. Documented diagnosis of primary hypogonadism (congenital or acquired) or
hypogonadotropic hypogonadism (congenital or acquired).

2. Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples

Exclusion Criteria:

A subject will not be eligible for study participation if he meets any of the following
criteria.

1. History of significant sensitivity or allergy to androgens, castor oil or product
excipients.

2. Clinically significant findings in the prestudy examinations.

3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS
score > 19 points.

4. Body mass index (BMI) ≥ 38 kg/m2.

5. Clinically significant abnormal laboratory values

6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B
surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human
immunodeficiency virus antibodies (HIV Ab).

7. History of seizures or convulsions, including febrile, alcohol or drug withdrawal
seizures.

8. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any
surgical procedure that might interfere with gastrointestinal motility, pH or
absorption.

9. History of any clinically significant illness, infection, or surgical procedure
within 1 month prior to study drug administration.

10. History of stroke or myocardial infarction within the past 5 years.

11. History of, or current or suspected, prostate or breast cancer.

12. History of diagnosed, severe, untreated, obstructive sleep apnea.

13. History of abuse of alcohol or any drug substance in the opinion of the investigator
within the previous 2 years.

14. History of long QT syndrome or unexplained sudden death in a first degree relative
(parent, sibling, or child).

15. Concurrent treatment with medications which may impact the absorption, distribution,
metabolism or excretion of testosterone undecanoate (TU) or place the subject at risk
for treatment with testosterone.

16. Subject has a partner who is currently pregnant or planning pregnancy during the
course of the clinical trial.
We found this trial at
28
sites
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
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Medford, OR
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303 Williams Ave
Huntsville, Alabama 35801
256-533-6603
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Huntsville, AL
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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Salt Lake City, UT
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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from
San Antonio, TX
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Austin, TX
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Bala Cynwyd, Pennsylvania 19004
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Bala Cynwyd, PA
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Birmingham, Alabama 35235
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Birmingham, AL
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Boise, Idaho 83704
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Boise, ID
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Bradenton, Florida
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Bradenton, FL
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Brandon, Florida 33511
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Brandon, FL
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Clearwater, Florida 33756
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Clearwater, FL
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801 Monterey Street
Coral Gables, Florida 33134
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Coral Gables, FL
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Dallas, Texas 75010
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Dallas, TX
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Hollywood, Florida 33024
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Hollywood, FL
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Hurst, Texas 76054
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Hurst, TX
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Jupiter, Florida 33458
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Jupiter, FL
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Lake Charles, Louisiana 70601
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Lake Charles, LA
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Lakeland, Florida 33805
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Lakeland, FL
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Little Rock, Arkansas 72205
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Little Rock, AR
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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New York, New York 10016
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New York, NY
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Oviedo, Florida 32765
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Oviedo, FL
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Phoenix, Arizona 85027
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Phoenix, AZ
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Renton, Washington 98057
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Renton, WA
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Richmond, VA
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San Diego, California 92120
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San Diego, CA
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St.Petersburg, Florida 33709
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St.Petersburg, FL
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Torrance, California 90502
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Torrance, CA
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