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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02081300
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : October 23, 2017
Sponsor:
Collaborators:
Syneos Health
PPD
Information provided by (Responsible Party):
Lipocine Inc.

Tracking Information
First Submitted Date  ICMJE February 20, 2014
First Posted Date  ICMJE March 7, 2014
Last Update Posted Date October 23, 2017
Study Start Date  ICMJE February 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2014)
  • 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 ]
  • 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 ]
  • Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA) [ Time Frame: 52 weeks ]
  • Number of subjects with adverse events during 52 weeks of treatment [ Time Frame: 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
Official Title  ICMJE Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Male Hypogonadism
Intervention  ICMJE
  • Drug: Oral testosterone undecanoate, LPCN 1021
  • Drug: Topical testosterone gel 1.62 %
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Oral testosterone undecanoate, LPCN 1021
  • 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
    Intervention: Drug: Topical testosterone gel 1.62 %
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)
315
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2014)
300
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02081300
Other Study ID Numbers  ICMJE LPCN 1021-13-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lipocine Inc.
Study Sponsor  ICMJE Lipocine Inc.
Collaborators  ICMJE
  • Syneos Health
  • PPD
Investigators  ICMJE
Study Director: Anthony DelConte, MD Chief Medical Director, Lipocine, Inc.
PRS Account Lipocine Inc.
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP