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

Phase 3

Completed

• Conditions: Male Hypogonadism
• Interventions: Drug: Oral testosterone undecanoate, LPCN 1021; Drug: Topical testosterone gel 1.62 %

• Registration Number: NCT02081300
• Lead Sponsor: Lipocine Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-07
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-10
• Disposition First Submitted: 2017-10-19
• Disposition First Submitted QC: 2017-10-19
• Last Update Submitted: 2017-10-19
• Disposition First Posted: 2017-10-23
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 315

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral testosterone undecanoate, LPCN 1021	Oral testosterone undecanoate, LPCN 1021	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 %	Topical testosterone gel 1.62 %	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

Primary Outcome Measures

Name	Time	Method
Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.	Following 13 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Percentage of LPCN 1021-treated subjects with maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng/dL; (b) between 1800 and 2500 ng/dL, and (c) greater than 2500 ng/dL	Following 13 weeks of treatment
Change from baseline in patient reported outcomes for LPCN 1021 (i.e., International Prostate Symptom Score [I-PSS], Psychosexual Daily Questionnaire [PDQ], Short Form-36 Questionnaire [SF-36])	52 weeks
Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA)	52 weeks
Number of subjects with adverse events during 52 weeks of treatment	52 weeks