Trial | NCT02081300  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    testosterone ...

  • Study Participants

    315
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.
Study Started
Feb 28
2014
Primary Completion
May 31
2015
Study Completion
May 31
2015
Last Update
Oct 23
2017

Drug Topical testosterone gel 1.62 %

Drug Oral testosterone undecanoate, LPCN 1021

Oral testosterone undecanoate, LPCN 1021 Experimental

Oral testosterone undecanoate: Initial dose: 225 mg TU BID. Dose titrated up to 300 mg TU BID or down to 150 mg TU BID based on serum T at Week 3 and 7.

Topical testosterone gel 1.62 % Other

Topical testosterone gel 1.62%: Initial dose: 40.5 mg T once daily. Dose titrated down to 20.25 mg or up to 81 mg based on serum T on Days 14 and 28

Criteria 

Inclusion Criteria:

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

History of significant sensitivity or allergy to androgens, castor oil or product excipients.
Clinically significant findings in the prestudy examinations.
Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score > 19 points.
Body mass index (BMI) ≥ 38 kg/m2.
Clinically significant abnormal laboratory values
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).
History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
History of stroke or myocardial infarction within the past 5 years.
History of, or current or suspected, prostate or breast cancer.
History of diagnosed, severe, untreated, obstructive sleep apnea.
History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
History of long QT syndrome or unexplained sudden death in a first degree relative (parent, sibling, or child).
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.
Subject has a partner who is currently pregnant or planning pregnancy during the course of the clinical trial.
No Results Posted