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

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.

Study Overview

• Status: Completed
• Conditions: Male Hypogonadism
• Intervention / Treatment: Drug: Oral testosterone undecanoate, LPCN 1021; Drug: Topical testosterone gel 1.62 %

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Oral testosterone undecanoate, LPCN 1021
Other: 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	Drug: Topical testosterone gel 1.62 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Lipocine Inc.
• Collaborators: PPD; Syneos Health
• Investigators: Study Director: Anthony DelConte, MD, Chief Medical Director, Lipocine, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 7, 2014

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Hypogonadism; Antineoplastic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Endocrine System Diseases; Testosterone; Androgens; Hormones; Antineoplastic Agents, Hormonal; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone enanthate; Low testosterone; Gonadal Disorders; Testosterone undecanoate; Testosterone 17 beta-cypionate; Methyltestosterone; Anabolic Agents; Male hypogonadism; LPCN 1021; Androgel; Testim; Testopel; Fortesta; Axiron.; Eunuchism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: LPCN 1021-13-001