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

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ClinicalTrials.gov Identifier: NCT02081300
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : October 23, 2017
Sponsor:
Collaborators:
INC Research
PPD
Information provided by (Responsible Party):
Lipocine Inc.

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.

Condition or disease Intervention/treatment Phase
Male Hypogonadism Drug: Oral testosterone undecanoate, LPCN 1021 Drug: Topical testosterone gel 1.62 % Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


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
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 %



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA) [ Time Frame: 52 weeks ]
  4. Number of subjects with adverse events during 52 weeks of treatment [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081300


Sponsors and Collaborators
Lipocine Inc.
INC Research
PPD
Investigators
Study Director: Anthony DelConte, MD Chief Medical Director, Lipocine, Inc.

Responsible Party: Lipocine Inc.
ClinicalTrials.gov Identifier: NCT02081300     History of Changes
Other Study ID Numbers: LPCN 1021-13-001
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017

Keywords provided by Lipocine Inc.:
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

Additional relevant MeSH terms:
Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgens
Hormones
Physiological Effects of Drugs
Anabolic Agents