Safety and Efficacy Trial of Testosterone Undecanoate

PHASE3CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Male Hypogonadism
Interventions
DRUG

Oral testosterone undecanoate

Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.

Trial Locations (27)

10016

University Urology Associates, New York

19004

Unrologic Consultants of SE Pennsylvania, Bala-Cynwyd

32223

Jacksonville Impotence Treatment Center, Jacksonville

33180

South Florida Medical Research, Aventura

33511

PAB Clinical Research, Brandon

33756

Innovative Research of West Florida, Clearwater

35235

Alabama Clinical Therapeutics, LLC, Birmingham

Alabama Internal Medicine, PC, Birmingham

35801

Medical Affliated Research Center, Inc., Huntsville

75010

Research Across America, Carrollton

75234

Research Across America, Dallas

76053

Potenium Clinical Research, LLC, Hurst

77074

Clinical Trial Network, Houston

78229

Clinical Trials of Texas, Inc., San Antonio

85027

Premier Clinical Research Center, Phoenix

85032

Precision Trials/Valley Urologic Associates, Phoenix

85308

Precision Trials/Valley Urologic Associates, Glendale

85712

Quality of LIfe Medical and Research Center, Tucson

90048

Tower Urology, Tower Research Institute, Los Angeles

90502

LABiomedical Research Institute at Harbor-UCLA Medical Center, Torrance

92120

San Diego Sexual Medicine, San Diego

92653

South ORange County Endocrinology, Laguna Hill

92844

SC Clinical Research, Inc., Garden Grove

97504

Sunstone Medical Research, Medford

98057

Rainer Clinical Research Center, Inc., Renton

98195

University of Washington, Seattle

06762

Conneticut Clinical Research Center, Middlebury

Sponsors
All Listed Sponsors
collaborator

inVentiv Health Clinical

OTHER

lead

Clarus Therapeutics, Inc.

INDUSTRY