Back to resultsA Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Primary Purpose
Hypogonadism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AndroGel 1.62%
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring Hypogonadism, Testosterone Replacement Therapy, AndroGel
Eligibility Criteria
Inclusion Criteria:
Diagnosis of hypogonadism with the presence of at least one of the following symptoms that may be related to low testosterone values and is/are consistent with hypogonadism:
- Decreased sexual desire or libido
- Decreased spontaneous erections (e.g. morning erections)
- Decreased energy or fatigue/feeling tired
- Low mood or depressed mood
- Loss of body (axillary and pubic) hair or reduced shaving
- Hot flashes AND
- Confirmed by 2 serum testosterone levels < 300 ng/dL by blood samples drawn at least 48 hours apart. These samples should be obtained between 5 am and 11 am local time.
- Blood pressure >100/60 mmHg and <140/90 mmHg
Exclusion Criteria:
- Unprovoked deep vein thrombosis (DVT), unprovoked pulmonary embolism (PE), or known thrombophilia
- Polycythemia vera or secondary polycythemia, such as polycythemia due to untreated sleep apnea or severe chronic obstructive pulmonary disease
- Prostate or breast cancer
- Any active malignancy
- Clinically significant medical conditions or any other reason that the investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug
- Work night shifts or is otherwise required to perform strenuous manual labor while wearing the Ambulatory Blood Pressure Monitor (ABPM).
Sites / Locations
- G & L Research, LLC /ID# 216793
- NewportNativeMD, Inc. /ID# 216992
- Valley Renal Medical Group Research /ID# 216321
- West Coast Research LLC /ID# 216813
- Lynn Institute of Denver /ID# 216863
- Innovative Research of West Florida /ID# 216364
- Seidman Clinical Trials,Delray /ID# 216794
- Invesclinic, U.S., LLC /ID# 216778
- Indago Research and Health Cen /ID# 216319
- Care Partners Clinical Research /ID# 216773
- Pharmax Research Clinic /ID# 216343
- Care Research center Inc. /ID# 216367
- West Orange Endocrinology /ID# 217106
- North Georgia Clinical Research /ID# 216864
- Solaris Clinical Research /ID# 216772
- Loretto Hospital.Affnity Clinical Research Institute /ID# 216884
- Affinity Clinical Research /ID# 216807
- Investigative Clinical Research of Indiana, LLC /ID# 216943
- Iowa Diabetes and Endocrinology Research Center /ID# 216316
- PRN Professional Research Network of Kansas, LLC /ID# 216805
- The Research Grp of Lexington /ID# 216451
- Centennial Medical Group /ID# 216340
- Advanced Biomedical Research of America /ID# 216797
- Amici Clinical Research /ID# 216779
- NM Clinical Research & Osteoporosis Center, Inc /ID# 216808
- AccuMed Research Associates /ID# 216775
- Randolph Health Internal Medicine /ID# 216366
- OnSite Clinical Solutions, LLC /ID# 216279
- OnSite Clinical Solutions, LLC /ID# 216368
- Triad Clinical Trials /ID# 216792
- Lucas Research /ID# 216487
- Diabetes and Endocrinology Associates of Stark County Inc /ID# 216362
- Intend Research /ID# 216320
- Tristar Clinical Investigations PC /ID# 216944
- Frontier Clinical Research /ID# 216365
- New Phase Research & Development /ID# 216774
- Clinical Neuroscience Solutions - Memphis /ID# 216790
- Arlington Family Research Center, Inc /ID# 216363
- Associates in Medicine, P.A. /ID# 216781
- FMC Science /ID# 216318
- Discovery Clinical Trials-San Antonio /ID# 216866
- Northwest Houston Clinical Research PLLC /ID# 216358
- Burke Internal Medicine & Research /ID# 216322
- Manassas Clinical Research Center /ID# 216313
- Virginia Research Center /ID# 216341
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AndroGel 1.62%
Arm Description
AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study, for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.
Outcomes
Primary Outcome Measures
Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)
Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04274894
Brief Title
A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Official Title
24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
January 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypogonadism is an endocrine disorder characterized by absent or deficient testosterone levels along with signs and symptoms of androgen deficiency, including delayed development or regression of sexual characteristics, impaired sexual function and sense of well-being, depressed mood, decreased muscle strength associated with loss of muscle mass and reduced bone mineral density. AndroGel 1.62% has demonstrated its ability to increase total testosterone levels in the blood by absorption of testosterone through the skin when applied topically. This study evaluated the effect of AndroGel 1.62% on systolic blood pressure using ambulatory blood pressure monitoring in hypogonadal men who used testosterone replacement therapy.
AndroGel 1.62% is a drug used for the treatment of hypogonadism, which is associated with low or no testosterone. This was an open-label study which means that both the study doctor and study participants knew what drug and what dose is being used. All participants in this study were in the same group, called a treatment arm. Adult male participants with hypogonadism were enrolled and received AndroGel 1.62%. This was a multi-center study with 190 participants enrolled (initially planned) in approximately 45 sites in the United States to yield 171 subjects in the per protocol (PP) population. A blinded sample size re-estimation (BSSR) was performed when around 70% of the planned subjects in the PP population had completed the end of treatment visit. Sample size was increased at BSSR and 246 participants were actually enrolled.
Participants received daily topical gel doses of AndroGel 1.62% for approximately 16 weeks.
There may have been a higher burden for participants in this study compared to standard of care. Participants attended 8 study visits during the course of the study at a hospital or clinic and received 2 study phone calls. The effect of the treatment was checked by medical assessments, blood tests (including pharmacokinetic sampling), and 24-hour blood pressure monitors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Hypogonadism, Testosterone Replacement Therapy, AndroGel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AndroGel 1.62%
Arm Type
Experimental
Arm Description
AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study, for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.
Intervention Type
Drug
Intervention Name(s)
AndroGel 1.62%
Other Intervention Name(s)
Testosterone gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)
Description
Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day).
Time Frame
Baseline, Week 16
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of hypogonadism with the presence of at least one of the following symptoms that may be related to low testosterone values and is/are consistent with hypogonadism:
Decreased sexual desire or libido
Decreased spontaneous erections (e.g. morning erections)
Decreased energy or fatigue/feeling tired
Low mood or depressed mood
Loss of body (axillary and pubic) hair or reduced shaving
Hot flashes AND
Confirmed by 2 serum testosterone levels < 300 ng/dL by blood samples drawn at least 48 hours apart. These samples should be obtained between 5 am and 11 am local time.
Blood pressure >100/60 mmHg and <140/90 mmHg
Exclusion Criteria:
Unprovoked deep vein thrombosis (DVT), unprovoked pulmonary embolism (PE), or known thrombophilia
Polycythemia vera or secondary polycythemia, such as polycythemia due to untreated sleep apnea or severe chronic obstructive pulmonary disease
Prostate or breast cancer
Any active malignancy
Clinically significant medical conditions or any other reason that the investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug
Work night shifts or is otherwise required to perform strenuous manual labor while wearing the Ambulatory Blood Pressure Monitor (ABPM).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
G & L Research, LLC /ID# 216793
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
NewportNativeMD, Inc. /ID# 216992
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3600
Country
United States
Facility Name
Valley Renal Medical Group Research /ID# 216321
City
Northridge
State/Province
California
ZIP/Postal Code
91324-4622
Country
United States
Facility Name
West Coast Research LLC /ID# 216813
City
San Ramon
State/Province
California
ZIP/Postal Code
94582
Country
United States
Facility Name
Lynn Institute of Denver /ID# 216863
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Innovative Research of West Florida /ID# 216364
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756-2004
Country
United States
Facility Name
Seidman Clinical Trials,Delray /ID# 216794
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484-6529
Country
United States
Facility Name
Invesclinic, U.S., LLC /ID# 216778
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Indago Research and Health Cen /ID# 216319
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-4170
Country
United States
Facility Name
Care Partners Clinical Research /ID# 216773
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32277
Country
United States
Facility Name
Pharmax Research Clinic /ID# 216343
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Care Research center Inc. /ID# 216367
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
West Orange Endocrinology /ID# 217106
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761-4547
Country
United States
Facility Name
North Georgia Clinical Research /ID# 216864
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Solaris Clinical Research /ID# 216772
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Loretto Hospital.Affnity Clinical Research Institute /ID# 216884
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60644
Country
United States
Facility Name
Affinity Clinical Research /ID# 216807
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523-1245
Country
United States
Facility Name
Investigative Clinical Research of Indiana, LLC /ID# 216943
City
Elwood
State/Province
Indiana
ZIP/Postal Code
46036-3341
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center /ID# 216316
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
PRN Professional Research Network of Kansas, LLC /ID# 216805
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
The Research Grp of Lexington /ID# 216451
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503-2969
Country
United States
Facility Name
Centennial Medical Group /ID# 216340
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Advanced Biomedical Research of America /ID# 216797
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Amici Clinical Research /ID# 216779
City
Warren
State/Province
New Jersey
ZIP/Postal Code
07059
Country
United States
Facility Name
NM Clinical Research & Osteoporosis Center, Inc /ID# 216808
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
AccuMed Research Associates /ID# 216775
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Randolph Health Internal Medicine /ID# 216366
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
OnSite Clinical Solutions, LLC /ID# 216279
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
OnSite Clinical Solutions, LLC /ID# 216368
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Triad Clinical Trials /ID# 216792
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Lucas Research /ID# 216487
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Diabetes and Endocrinology Associates of Stark County Inc /ID# 216362
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Intend Research /ID# 216320
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Tristar Clinical Investigations PC /ID# 216944
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114-1025
Country
United States
Facility Name
Frontier Clinical Research /ID# 216365
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
New Phase Research & Development /ID# 216774
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Clinical Neuroscience Solutions - Memphis /ID# 216790
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Arlington Family Research Center, Inc /ID# 216363
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Associates in Medicine, P.A. /ID# 216781
City
Houston
State/Province
Texas
ZIP/Postal Code
77027-3103
Country
United States
Facility Name
FMC Science /ID# 216318
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Discovery Clinical Trials-San Antonio /ID# 216866
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Northwest Houston Clinical Research PLLC /ID# 216358
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Burke Internal Medicine & Research /ID# 216322
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015-2234
Country
United States
Facility Name
Manassas Clinical Research Center /ID# 216313
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110-4421
Country
United States
Facility Name
Virginia Research Center /ID# 216341
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114-3256
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
Related Info.
Learn more about this trial
A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
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