search
Back to results

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

Primary Purpose

Male Hypogonadism

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Oral testosterone undecanoate, LPCN 1021
Topical testosterone gel 1.62 %
Sponsored by
Lipocine Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Hypogonadism focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Oral testosterone undecanoate, LPCN 1021

    Topical testosterone gel 1.62 %

    Arm Description

    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%: 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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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
    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])
    Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA)
    Number of subjects with adverse events during 52 weeks of treatment

    Full Information

    First Posted
    February 20, 2014
    Last Updated
    October 19, 2017
    Sponsor
    Lipocine Inc.
    Collaborators
    Syneos Health, PPD
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02081300
    Brief Title
    Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
    Acronym
    SOAR
    Official Title
    Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lipocine Inc.
    Collaborators
    Syneos Health, PPD

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    315 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral testosterone undecanoate, LPCN 1021
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Topical testosterone gel 1.62 %
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Oral testosterone undecanoate, LPCN 1021
    Intervention Type
    Drug
    Intervention Name(s)
    Topical testosterone gel 1.62 %
    Primary Outcome Measure Information:
    Title
    Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.
    Time Frame
    Following 13 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    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
    Time Frame
    Following 13 weeks of treatment
    Title
    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])
    Time Frame
    52 weeks
    Title
    Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA)
    Time Frame
    52 weeks
    Title
    Number of subjects with adverse events during 52 weeks of treatment
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anthony DelConte, MD
    Organizational Affiliation
    Chief Medical Director, Lipocine, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs