Clinical trial NCT02081300: Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
Official title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Lipocine Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
name: PPD Development, LP
First posted: 2014-03-07
Enrollment: 315
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.
timeFrame: Following 13 weeks of treatment
Secondary outcomes:
measure: 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
timeFrame: Following 13 weeks of treatment
measure: 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])
timeFrame: 52 weeks
measure: Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA)
timeFrame: 52 weeks
measure: Number of subjects with adverse events during 52 weeks of treatment
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chief Medical Director, Lipocine, Inc.
name: Anthony DelConte, MD
role: STUDY_DIRECTOR
References: