Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men

PHASE3CompletedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

July 5, 2017

Primary Completion Date

May 1, 2020

Study Completion Date

May 1, 2020

Conditions
Hypogonadism, Male
Interventions
DRUG

SOV2012-F1

oral preparation of testosterone undecanoate (TU)

DRUG

AndroGel

topical testosterone gel 1.62%

Trial Locations (36)

10016

Manhattan Medical Research Practice, PLLC, New York

11530

Accumed Research Associates, Garden City

19004

Urologic Consultants of SE Pennsylvania, Bala-Cynwyd

23294

National Clinical Research, Inc., Richmond

23507

Clinical Research Associates of Tidewater, Norfolk

28314

Rapha Institute For Clinical Research, Fayetteville

29464

Coastal Carolina Research Center, Mt. Pleasant

30312

Primary Care Research Group, Atlanta

32223

Jacksonville Impotence Treatment Center, Jacksonville

32765

Oviedo Medical Research, LLC, Oviedo

33155

My Community Research Center, Miami

33180

South Florida Medical Research, Aventura

33458

Health Awareness, Inc., Jupiter

33511

PAB Clinical Research, Brandon

33709

Meridien Research, St. Petersburg

33756

Innovative Research of West Florida, Inc., Clearwater

33805

Meridien Research, Lakeland

35205

Central Research Associates, Inc., Birmingham

35235

Alabama Clinical Therapeutics, LLC, Birmingham

36608

Coastal Clinical Research, Inc., Mobile

37411

University Diabetes Endocrine Consultants, Chattanooga

40509

Central Kentucky Research Associates, Lexington

43213

Aventiv Research, Inc., Columbus

68114

Quality Clinical Research, Inc., Omaha

70601

Centex Studies, Inc., Lake Charles

77058

Centex Studies, Inc., Houston

77099

Pioneer Research Solutions, Inc., Houston

83642

Advanced Clinical Research, Meridian

83704

Northwest Clinical Trials, Boise

84088

Advanced Clinical Research, West Jordan

85712

Quality of Life Medical and Research Centers, LLC, Tucson

89148

Palm Research Center, Inc., Las Vegas

92120

San Diego Sexual Medicine, San Diego

98057

Rainier Clinical Research Center, Inc., Renton

99352

Mid-Columbia Research, Richland

02467

Men's Health Boston, Chestnut Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Marius Pharmaceuticals

INDUSTRY

NCT03198728 - Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men | Biotech Hunter | Biotech Hunter