Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

PHASE3CompletedINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Male Hypogonadism
Interventions
DRUG

Oral testosterone undecanoate

Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID

DRUG

Transdermal testosterone gel (AndroGel)

Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD

Trial Locations (30)

10016

University Urology Associates, New York

10577

Michael A. Werner, Purchase

11021

Bruce R. Gilbert, MD, PhD, Great Neck

11235

Maimonides Medical Center, Brooklyn

19004

Urologic Consultants of Southeast Pennsylvania, Bala-Cynwyd

21287

Johns Hopkins University, Baltimore

33180

South Florida Medical Research, Aventura

35040

Alabama Clinical Therapeutics, Calera

35235

Alabama Clinical Therapeutics, Inc., Birmingham

Alabama Internal Medicine, PC, Birmingham

35801

Medical Affiliated Research Center, Inc, Huntsville

40202

University of Louisville, Louisville

48149

University of Muenster, Center for Reproduction and Andrology, Münster

53105

University of Bonn, Clinic for Dermatology and Allergy, Bonn

75010

Research Across America, Carrollton

75234

Research Across America, Dallas

85712

Quality of Life Medical and Research Centers, LLC, Tucson

90048

Tower Urology, Los Angeles

90095

David Geffen School of Medicine, UCLA, Los Angeles

90502

Harbor-UCLA Medical Center, LA Biomedical Research Institute, Torrance

91505

Providence Clinical Research, Burbank

92653

South Orange County Endocrinology, Laguna Hills

97504

Sunstone Medical Research, Medford

98195

University of Washington, Seattle

06762

Connecticut Clinical Research Center/ConnecTrials, Middlebury

06511

University of CT School of Medicine, New Haven

02118

Boston University School of Medicine, Boston

06120

University of Halle, Center for Reproduction and Andrology, Halle

04105

Praxis Dr. Szymula, Leipzig

04416

Praxis Dr. Schulze, Markkleeberg

Sponsors
All Listed Sponsors
lead

Clarus Therapeutics, Inc.

INDUSTRY

NCT01699178 - Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men | Biotech Hunter | Biotech Hunter