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

24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy

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.

Study Overview

• Status: Completed
• Conditions: Hypogonadism
• Intervention / Treatment: Drug: AndroGel 1.62%

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.; Other Names: Testosterone gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Week 16

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related Info.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): January 7, 2022

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Hypogonadism; AndroGel; Testosterone Replacement Therapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: M19-161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• 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