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

NCT02081300 | Completed Phase 3

• 1 other identifier: LPCN 1021-13-001
• Study Type: interventional
• Target: 315
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Male Hypogonadism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.

  Following 13 weeks of treatment

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

Drug: Oral testosterone undecanoate, LPCN 1021

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

Drug: Topical testosterone gel 1.62 %

Interventions

Oral testosterone undecanoate, LPCN 1021 DRUG

Oral testosterone undecanoate, LPCN 1021

Topical testosterone gel 1.62 % DRUG

Topical testosterone gel 1.62 %

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lipocine Inc.: lead
• Syneos Health: collaborator
• PPD Development, LP: collaborator

MeSH Terms

Conditions

Eunuchism; Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Interventions

testosterone undecanoate; Testosterone Propionate

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Anthony DelConte, MD

  Chief Medical Director, Lipocine, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: March 7, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 23, 2017

Record last verified: 2017-10