A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
NCT ID: NCT04685993
Last Updated: 2024-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2020-11-11
2022-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment A
LPCN 1144
LPCN 1144
Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
Interventions
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LPCN 1144
Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject must sign the Informed Consent Form to participate in the study
Exclusion Criteria
2. Subjects who are currently receiving any androgens or estrogens
3. Subjects who are not willing to use adequate contraception for the duration of the study
4. Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to enrollment
5. Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
18 Years
80 Years
MALE
No
Sponsors
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Lipocine Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anthony DelConte
Role: STUDY_DIRECTOR
Lipocine Inc.
Locations
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Clinical Trials Research
Roseville, California, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
R&H Clinical Research
Katy, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Pioneer Research Soultions
Sugar Land, Texas, United States
Advanced Clinical Research - Gut Whisperer
Riverton, Utah, United States
Granger Medical Clinic
West Valley City, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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LPCN 1144-20-002
Identifier Type: -
Identifier Source: org_study_id
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