A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
NCT ID: NCT04274894
Last Updated: 2022-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
246 participants
INTERVENTIONAL
2020-05-12
2022-01-07
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AndroGel 1.62%
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
MALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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G & L Research, LLC /ID# 216793
Foley, Alabama, United States
NewportNativeMD, Inc. /ID# 216992
Newport Beach, California, United States
Valley Renal Medical Group Research /ID# 216321
Northridge, California, United States
West Coast Research LLC /ID# 216813
San Ramon, California, United States
Lynn Institute of Denver /ID# 216863
Aurora, Colorado, United States
Innovative Research of West Florida /ID# 216364
Clearwater, Florida, United States
Seidman Clinical Trials,Delray /ID# 216794
Delray Beach, Florida, United States
Invesclinic, U.S., LLC /ID# 216778
Fort Lauderdale, Florida, United States
Indago Research and Health Cen /ID# 216319
Hialeah, Florida, United States
Care Partners Clinical Research /ID# 216773
Jacksonville, Florida, United States
Pharmax Research Clinic /ID# 216343
Miami, Florida, United States
Care Research center Inc. /ID# 216367
Miami, Florida, United States
West Orange Endocrinology /ID# 217106
Ocoee, Florida, United States
North Georgia Clinical Research /ID# 216864
Woodstock, Georgia, United States
Solaris Clinical Research /ID# 216772
Meridian, Idaho, United States
Loretto Hospital.Affnity Clinical Research Institute /ID# 216884
Chicago, Illinois, United States
Affinity Clinical Research /ID# 216807
Oak Brook, Illinois, United States
Investigative Clinical Research of Indiana, LLC /ID# 216943
Elwood, Indiana, United States
Iowa Diabetes and Endocrinology Research Center /ID# 216316
West Des Moines, Iowa, United States
PRN Professional Research Network of Kansas, LLC /ID# 216805
Wichita, Kansas, United States
The Research Grp of Lexington /ID# 216451
Lexington, Kentucky, United States
Centennial Medical Group /ID# 216340
Elkridge, Maryland, United States
Advanced Biomedical Research of America /ID# 216797
Las Vegas, Nevada, United States
Amici Clinical Research /ID# 216779
Warren Township, New Jersey, United States
NM Clinical Research & Osteoporosis Center, Inc /ID# 216808
Albuquerque, New Mexico, United States
AccuMed Research Associates /ID# 216775
Garden City, New York, United States
Randolph Health Internal Medicine /ID# 216366
Asheboro, North Carolina, United States
OnSite Clinical Solutions, LLC /ID# 216279
Charlotte, North Carolina, United States
OnSite Clinical Solutions, LLC /ID# 216368
Charlotte, North Carolina, United States
Triad Clinical Trials /ID# 216792
Greensboro, North Carolina, United States
Lucas Research /ID# 216487
Morehead City, North Carolina, United States
Diabetes and Endocrinology Associates of Stark County Inc /ID# 216362
Canton, Ohio, United States
Intend Research /ID# 216320
Norman, Oklahoma, United States
Tristar Clinical Investigations PC /ID# 216944
Philadelphia, Pennsylvania, United States
Frontier Clinical Research /ID# 216365
Smithfield, Pennsylvania, United States
New Phase Research & Development /ID# 216774
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions - Memphis /ID# 216790
Memphis, Tennessee, United States
Arlington Family Research Center, Inc /ID# 216363
Arlington, Texas, United States
Associates in Medicine, P.A. /ID# 216781
Houston, Texas, United States
FMC Science /ID# 216318
Lampasas, Texas, United States
Discovery Clinical Trials-San Antonio /ID# 216866
San Antonio, Texas, United States
Northwest Houston Clinical Research PLLC /ID# 216358
Tomball, Texas, United States
Burke Internal Medicine & Research /ID# 216322
Burke, Virginia, United States
Manassas Clinical Research Center /ID# 216313
Manassas, Virginia, United States
Virginia Research Center /ID# 216341
Midlothian, Virginia, United States
Countries
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References
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Weber MA, Aslam S, Efros MD, Chan A, Khan N, Li X, Dubcenco E, Miller MG. Single-arm study of testosterone gel replacement therapy and ambulatory blood pressure outcomes in men with hypogonadism. Andrology. 2025 Sep;13(6):1390-1401. doi: 10.1111/andr.13779. Epub 2024 Oct 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info.
Other Identifiers
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M19-161
Identifier Type: -
Identifier Source: org_study_id