Clinical trial NCT04274894: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadism
Keywords: Hypogonadism
Testosterone Replacement Therapy
AndroGel
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-02-18
Enrollment: 246
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Foley
country: United States
facility: G & L Research, LLC /ID# 216793
state: Alabama
city: Newport Beach
country: United States
facility: NewportNativeMD, Inc. /ID# 216992
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group Research /ID# 216321
state: California
city: San Ramon
country: United States
facility: West Coast Research LLC /ID# 216813
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver /ID# 216863
state: Colorado
city: Clearwater
country: United States
facility: Innovative Research of West Florida /ID# 216364
state: Florida
city: Delray Beach
country: United States
facility: Seidman Clinical Trials,Delray /ID# 216794
state: Florida
city: Fort Lauderdale
country: United States
facility: Invesclinic, U.S., LLC /ID# 216778
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Cen /ID# 216319
state: Florida
city: Jacksonville
country: United States
facility: Care Partners Clinical Research /ID# 216773
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic /ID# 216343
state: Florida
city: Miami
country: United States
facility: Care Research center Inc. /ID# 216367
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology /ID# 217106
state: Florida
city: Woodstock
country: United States
facility: North Georgia Clinical Research /ID# 216864
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research /ID# 216772
state: Idaho
city: Chicago
country: United States
facility: Loretto Hospital.Affnity Clinical Research Institute /ID# 216884
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Clinical Research /ID# 216807
state: Illinois
city: Elwood
country: United States
facility: Investigative Clinical Research of Indiana, LLC /ID# 216943
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center /ID# 216316
state: Iowa
city: Wichita
country: United States
facility: PRN Professional Research Network of Kansas, LLC /ID# 216805
state: Kansas
city: Lexington
country: United States
facility: The Research Grp of Lexington /ID# 216451
state: Kentucky
city: Elkridge
country: United States
facility: Centennial Medical Group /ID# 216340
state: Maryland
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America /ID# 216797
state: Nevada
city: Warren
country: United States
facility: Amici Clinical Research /ID# 216779
state: New Jersey
city: Albuquerque
country: United States
facility: NM Clinical Research & Osteoporosis Center, Inc /ID# 216808
state: New Mexico
city: Garden City
country: United States
facility: AccuMed Research Associates /ID# 216775
state: New York
city: Asheboro
country: United States
facility: Randolph Health Internal Medicine /ID# 216366
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC /ID# 216279
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC /ID# 216368
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials /ID# 216792
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research /ID# 216487
state: North Carolina
city: Canton
country: United States
facility: Diabetes and Endocrinology Associates of Stark County Inc /ID# 216362
state: Ohio
city: Norman
country: United States
facility: Intend Research /ID# 216320
state: Oklahoma
city: Philadelphia
country: United States
facility: Tristar Clinical Investigations PC /ID# 216944
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research /ID# 216365
state: Pennsylvania
city: Knoxville
country: United States
facility: New Phase Research & Development /ID# 216774
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions - Memphis /ID# 216790
state: Tennessee
city: Arlington
country: United States
facility: Arlington Family Research Center, Inc /ID# 216363
state: Texas
city: Houston
country: United States
facility: Associates in Medicine, P.A. /ID# 216781
state: Texas
city: Lampasas
country: United States
facility: FMC Science /ID# 216318
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials-San Antonio /ID# 216866
state: Texas
city: Tomball
country: United States
facility: Northwest Houston Clinical Research PLLC /ID# 216358
state: Texas
city: Burke
country: United States
facility: Burke Internal Medicine & Research /ID# 216322
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center /ID# 216313
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center /ID# 216341
state: Virginia
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: