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

Study Overview
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Brief Summary
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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.

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

Conditions
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Male Hypogonadism

Intervention / Treatment
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* Drug: Oral testosterone undecanoate, LPCN 1021
* Drug: Topical testosterone gel 1.62 %


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral testosterone undecanoate, LPCN 1021<br>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<br> <br> |
| Other: Topical testosterone gel 1.62 %<br>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 %<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testosterone, Male hypogonadism, Low testosterone, LPCN 1021, Androgel, Testim, Testopel, Fortesta, Axiron., Hypogonadism, Eunuchism, Gonadal Disorders, Endocrine System Diseases, Testosterone enanthate, Testosterone undecanoate, Testosterone 17 beta-cypionate, Methyltestosterone, Androgens, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Pharmacologic Actions, Antineoplastic Agents, Hormonal, Antineoplastic Agents, Anabolic Agents