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SUN-0089 : Safety of a New S.E.D.D.S. Formulation of Oral Testosterone Undecanoate (TU) in Hypogonadal Men: Data from Two Phase 3 Trials with Different Dose-Titration Algorithms

Researchers

Presenter

  • Ronald S. Swerdloff

Principal Investigators

  • Wael A. Salameh

  • Adrian S Dobs

  • Sandra M. Faulkner

  • Robert E. Dudley

  • Gregory M. Flippo

  • Jed C. Kaminetsky

  • John K. Amory

  • Theodore M. Danoff

  • Christina Wang

Medical Centers

  • Alabama Clinical Therapeutics, LLC, Pinson, AL

  • University Urology Associates, New York, NY

  • Harbor- Univ of California Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA

  • Univ of WA Med Ctr, Seattle, WA

  • Johns Hopkins University School of Medicine, Baltimore, MD

Locations

  • United States

Companies

  • Clarus Therapeutics,

Study Components

Therapeutic Area

  • Oncology (ONC)

  • Urology

Disease

  • Prostate cancer

Biomarkers

  • Prostate specific antigen

  • Enzyme lipoprotein-associated phospholipase A2

  • High sensitivity C-reactive protein

  • Telomerase reverse transcriptase

  • Testosterone

Drug/Treatment

  • LPCN 1111

  • Dihydrotestosterone

  • AndroGel

Outcome

  • N/A

Study Design

  • randomized

Phase

  • III

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • Final

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