A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

PHASE4CompletedINTERVENTIONAL
Enrollment

246

Participants

Timeline

Start Date

May 12, 2020

Primary Completion Date

December 7, 2021

Study Completion Date

January 7, 2022

Conditions
Hypogonadism
Interventions
DRUG

AndroGel 1.62%

AndroGel 1.62% was packaged in pump bottles with quantities sufficient to accommodate study design and could have been dose adjusted between a minimum of 20.25 mg of T (1 pump actuation) and a maximum of 81.0 mg of testosterone (4 pump actuations). For the first study drug administration at the Day 1 Visit, and also at Week 2, Week 4, Week 16 ambulatory blood pressure monitoring (ABPM,) and End of Treatment Visits, participants applied the study drug while on site so that the site staff could observe the proper administration of study drug. If participants forgot to apply their AndroGel 1.62% dose at their regularly scheduled dosing time, they were to take the next dose at the next dosing time.

Trial Locations (45)

11530

AccuMed Research Associates /ID# 216775, Garden City

15478

Frontier Clinical Research /ID# 216365, Smithfield

21075

Centennial Medical Group /ID# 216340, Elkridge

27203

Randolph Health Internal Medicine /ID# 216366, Asheboro

27410

Triad Clinical Trials /ID# 216792, Greensboro

28277

OnSite Clinical Solutions, LLC /ID# 216279, Charlotte

OnSite Clinical Solutions, LLC /ID# 216368, Charlotte

28557

Lucas Research /ID# 216487, Morehead City

30189

North Georgia Clinical Research /ID# 216864, Woodstock

32277

Care Partners Clinical Research /ID# 216773, Jacksonville

33126

Pharmax Research Clinic /ID# 216343, Miami

33175

Care Research center Inc. /ID# 216367, Miami

33308

Invesclinic, U.S., LLC /ID# 216778, Fort Lauderdale

36535

G & L Research, LLC /ID# 216793, Foley

37909

New Phase Research & Development /ID# 216774, Knoxville

38119

Clinical Neuroscience Solutions - Memphis /ID# 216790, Memphis

44718

Diabetes and Endocrinology Associates of Stark County Inc /ID# 216362, Canton

50265

Iowa Diabetes and Endocrinology Research Center /ID# 216316, West Des Moines

60644

Loretto Hospital.Affnity Clinical Research Institute /ID# 216884, Chicago

67205

PRN Professional Research Network of Kansas, LLC /ID# 216805, Wichita

73069

Intend Research /ID# 216320, Norman

76012

Arlington Family Research Center, Inc /ID# 216363, Arlington

76550

FMC Science /ID# 216318, Lampasas

77375

Northwest Houston Clinical Research PLLC /ID# 216358, Tomball

78258

Discovery Clinical Trials-San Antonio /ID# 216866, San Antonio

80012

Lynn Institute of Denver /ID# 216863, Aurora

83646

Solaris Clinical Research /ID# 216772, Meridian

87106

NM Clinical Research & Osteoporosis Center, Inc /ID# 216808, Albuquerque

89123

Advanced Biomedical Research of America /ID# 216797, Las Vegas

94582

West Coast Research LLC /ID# 216813, San Ramon

92663-3600

NewportNativeMD, Inc. /ID# 216992, Newport Beach

91324-4622

Valley Renal Medical Group Research /ID# 216321, Northridge

33756-2004

Innovative Research of West Florida /ID# 216364, Clearwater

33484-6529

Seidman Clinical Trials,Delray /ID# 216794, Delray Beach

33012-4170

Indago Research and Health Cen /ID# 216319, Hialeah

34761-4547

West Orange Endocrinology /ID# 217106, Ocoee

60523-1245

Affinity Clinical Research /ID# 216807, Oak Brook

46036-3341

Investigative Clinical Research of Indiana, LLC /ID# 216943, Elwood

40503-2969

The Research Grp of Lexington /ID# 216451, Lexington

07059

Amici Clinical Research /ID# 216779, Warren Township

19114-1025

Tristar Clinical Investigations PC /ID# 216944, Philadelphia

77027-3103

Associates in Medicine, P.A. /ID# 216781, Houston

22015-2234

Burke Internal Medicine & Research /ID# 216322, Burke

20110-4421

Manassas Clinical Research Center /ID# 216313, Manassas

23114-3256

Virginia Research Center /ID# 216341, Midlothian

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY