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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT04274894
Collaborator
(none)
246
Enrollment
45
Locations
1
Arm
22.4
Actual Duration (Months)
5.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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 will evaluate the effect of AndroGel 1.62% on systolic blood pressure using ambulatory blood pressure monitoring in hypogonadal men who use testosterone replacement therapy.

AndroGel 1.62% is a drug used for the treatment of hypogonadism, which is associated with low or no testosterone. This is an open-label study which means that both the study doctor and study participants will know what drug and what dose is being used. All participants in this study will be in the same group, called a treatment arm. Adult male participants with hypogonadism will be enrolled and receive AndroGel 1.62%. This is 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) will be performed when around 70% of the planned subjects in the PP population have completed the end of treatment visit.

Participants will receive daily topical gel doses of AndroGel 1.62% for approximately 16 weeks.

There may be a higher burden for participants in this study compared to standard of care. Participants will attend 8 study visits during the course of the study at a hospital or clinic and receive 2 study phone calls. The effect of the treatment will be checked by medical assessments, blood tests (including pharmacokinetic sampling), and 24-hour blood pressure monitors.

Condition or Disease Intervention/Treatment Phase
  • Drug: AndroGel 1.62%
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
246 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy
Actual Study Start Date :
Feb 24, 2020
Actual Primary Completion Date :
Dec 7, 2021
Actual Study Completion Date :
Jan 7, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: AndroGel

Participants will receive AndroGel 1.62% once daily

Drug: AndroGel 1.62%
Topical Gel
Other Names:
  • Testosterone Gel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline to end of treatment in 24-hour Average Systolic Blood Pressure (SBP) [Up to Approximately Week 16]

      Change in 24-hour Average Systolic Blood Pressure (SBP) will be assessed for participants using AndroGel as labelled.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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 public) 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 G & L Research, LLC /ID# 216793 Foley Alabama United States 36535
    2 NewportNativeMD, Inc. /ID# 216992 Newport Beach California United States 92663-3600
    3 Valley Renal Medical Group Research /ID# 216321 Northridge California United States 91324-4622
    4 West Coast Research LLC /ID# 216813 San Ramon California United States 94582
    5 Lynn Institute of Denver /ID# 216863 Aurora Colorado United States 80012
    6 Innovative Research of West Florida /ID# 216364 Clearwater Florida United States 33756-2004
    7 Seidman Clinical Trials,Delray /ID# 216794 Delray Beach Florida United States 33484-6529
    8 Invesclinic, U.S., LLC /ID# 216778 Fort Lauderdale Florida United States 33308-4602
    9 Indago Research and Health Cen /ID# 216319 Hialeah Florida United States 33012-4170
    10 Care Partners Clinical Research /ID# 216773 Jacksonville Florida United States 32277
    11 Pharmax Research Clinic /ID# 216343 Miami Florida United States 33126
    12 Care Research center Inc. /ID# 216367 Miami Florida United States 33175
    13 West Orange Endocrinology /ID# 217106 Ocoee Florida United States 34761-4547
    14 North Georgia Clinical Research /ID# 216864 Woodstock Georgia United States 30189
    15 Solaris Clinical Research /ID# 216772 Meridian Idaho United States 83646
    16 Loretto Hospital.Affnity Clinical Research Institute /ID# 216884 Chicago Illinois United States 60644
    17 Affinity Clinical Research /ID# 216807 Oak Brook Illinois United States 60523-1245
    18 Investigative Clinical Research of Indiana, LLC /ID# 216943 Elwood Indiana United States 46036-3341
    19 Iowa Diabetes and Endocrinology Research Center /ID# 216316 West Des Moines Iowa United States 50265
    20 PRN Professional Research Network of Kansas, LLC /ID# 216805 Wichita Kansas United States 67205
    21 The Research Grp of Lexington /ID# 216451 Lexington Kentucky United States 40503-2969
    22 Centennial Medical Group /ID# 216340 Elkridge Maryland United States 21075
    23 Advanced Biomedical Research of America /ID# 216797 Las Vegas Nevada United States 89123
    24 Amici Clinical Research /ID# 216779 Warren New Jersey United States 07059
    25 NM Clinical Research & Osteoporosis Center, Inc /ID# 216808 Albuquerque New Mexico United States 87106
    26 AccuMed Research Associates /ID# 216775 Garden City New York United States 11530
    27 Randolph Health Internal Medicine /ID# 216366 Asheboro North Carolina United States 27203
    28 OnSite Clinical Solutions, LLC /ID# 216279 Charlotte North Carolina United States 28277
    29 OnSite Clinical Solutions, LLC /ID# 216368 Charlotte North Carolina United States 28277
    30 Triad Clinical Trials /ID# 216792 Greensboro North Carolina United States 27410
    31 Lucas Research /ID# 216487 Morehead City North Carolina United States 28557
    32 Diabetes and Endocrinology Associates of Stark County Inc /ID# 216362 Canton Ohio United States 44718
    33 Intend Research /ID# 216320 Norman Oklahoma United States 73069
    34 Tristar Clinical Investigations PC /ID# 216944 Philadelphia Pennsylvania United States 19114-1025
    35 Frontier Clinical Research /ID# 216365 Smithfield Pennsylvania United States 15478
    36 New Phase Research & Development /ID# 216774 Knoxville Tennessee United States 37909
    37 Clinical Neuroscience Solutions - Memphis /ID# 216790 Memphis Tennessee United States 38119
    38 Arlington Family Research Center, Inc /ID# 216363 Arlington Texas United States 76012
    39 Associates in Medicine, P.A. /ID# 216781 Houston Texas United States 77027-3103
    40 FMC Science /ID# 216318 Lampasas Texas United States 76550
    41 Discovery Clinical Trials-San Antonio /ID# 216866 San Antonio Texas United States 78258
    42 Northwest Houston Clinical Research PLLC /ID# 216358 Tomball Texas United States 77375
    43 Burke Internal Medicine & Research /ID# 216322 Burke Virginia United States 22015-2234
    44 Manassas Clinical Research Center /ID# 216313 Manassas Virginia United States 20110-4421
    45 Virginia Research Center /ID# 216341 Midlothian Virginia United States 23114-3256

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04274894
    Other Study ID Numbers:
    • M19-161
    First Posted:
    Feb 18, 2020
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Hypogonadism
    Testosterone Replacement Therapy
    AndroGel
    Additional relevant MeSH terms:
    Hypogonadism
    Testosterone

    Study Results

    No Results Posted as of Feb 9, 2022