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

NCT ID: NCT02081300

Last Updated: 2017-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Male Hypogonadism

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Oral testosterone undecanoate, LPCN 1021

Intervention Type DRUG

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

Group Type OTHER

Topical testosterone gel 1.62 %

Intervention Type DRUG

Interventions

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Oral testosterone undecanoate, LPCN 1021

Intervention Type DRUG

Topical testosterone gel 1.62 %

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Syneos Health

OTHER

Sponsor Role collaborator

PPD Development, LP

INDUSTRY

Sponsor Role collaborator

Lipocine Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony DelConte, MD

Role: STUDY_DIRECTOR

Chief Medical Director, Lipocine, Inc.

Countries

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United States

Other Identifiers

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LPCN 1021-13-001

Identifier Type: -

Identifier Source: org_study_id