56
Participants
Start Date
August 27, 2019
Primary Completion Date
June 24, 2021
Study Completion Date
June 24, 2021
LPCN 1144 Formulation A
Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as 225 mg testosterone undecanoate twice daily (BID).
LPCN 1144 Formulation B
Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as 225 mg testosterone undecanoate + 238 mg d-alpha tocopherol BID
Placebo
Oral matching placebo capsule administered as BID
Manassas Clinical Research Center, Manassas
Meridien Research-Maitland, Maitland
Clinical Pharmacology of Miami, LLC, Miami
Sensible Healthcare, LLC, Ocoee
Awasty Research Network, Marion
Tandem Clinical Research, Marrero
Clinical Trial Network-Houston, Spring
Pioneer Research Soultions, Sugar Land
R&H Clinical Research, Katy
Sun Research Institute, San Antonio
Endeavor Clinical Trials, San Antonio
Advanced Clinical Research - Gut Whisperer, Riverton
Granger Medical Clinic, West Valley City
Jubilee Clinical Research, Inc., Las Vegas
Clinical Research of South Nevada, Las Vegas
TriWest Research Associates, LLC, El Cajon
Inland Empire Liver Foundation, Rialto
United Medical Doctors, Murrieta
Clinical Trials Research, Roseville
Lead Sponsor
Lipocine Inc.
INDUSTRY