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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04274894
• Other study ID #: M19-161
• Status: Completed
• Phase: Phase 4
• Start date: May 12, 2020
• Est. completion date: January 7, 2022

Study information

• Verified date: November 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: January 7, 2022
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hypogonadism

Intervention

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.

Locations

Country	Name	City	State
United States	NM Clinical Research & Osteoporosis Center, Inc /ID# 216808	Albuquerque	New Mexico
United States	Arlington Family Research Center, Inc /ID# 216363	Arlington	Texas
United States	Randolph Health Internal Medicine /ID# 216366	Asheboro	North Carolina
United States	Lynn Institute of Denver /ID# 216863	Aurora	Colorado
United States	Burke Internal Medicine & Research /ID# 216322	Burke	Virginia
United States	Diabetes and Endocrinology Associates of Stark County Inc /ID# 216362	Canton	Ohio
United States	OnSite Clinical Solutions, LLC /ID# 216279	Charlotte	North Carolina
United States	OnSite Clinical Solutions, LLC /ID# 216368	Charlotte	North Carolina
United States	Loretto Hospital.Affnity Clinical Research Institute /ID# 216884	Chicago	Illinois
United States	Innovative Research of West Florida /ID# 216364	Clearwater	Florida
United States	Seidman Clinical Trials,Delray /ID# 216794	Delray Beach	Florida
United States	Centennial Medical Group /ID# 216340	Elkridge	Maryland
United States	Investigative Clinical Research of Indiana, LLC /ID# 216943	Elwood	Indiana
United States	G & L Research, LLC /ID# 216793	Foley	Alabama
United States	Invesclinic, U.S., LLC /ID# 216778	Fort Lauderdale	Florida
United States	AccuMed Research Associates /ID# 216775	Garden City	New York
United States	Triad Clinical Trials /ID# 216792	Greensboro	North Carolina
United States	Indago Research and Health Cen /ID# 216319	Hialeah	Florida
United States	Associates in Medicine, P.A. /ID# 216781	Houston	Texas
United States	Care Partners Clinical Research /ID# 216773	Jacksonville	Florida
United States	New Phase Research & Development /ID# 216774	Knoxville	Tennessee
United States	FMC Science /ID# 216318	Lampasas	Texas
United States	Advanced Biomedical Research of America /ID# 216797	Las Vegas	Nevada
United States	The Research Grp of Lexington /ID# 216451	Lexington	Kentucky
United States	Manassas Clinical Research Center /ID# 216313	Manassas	Virginia
United States	Clinical Neuroscience Solutions - Memphis /ID# 216790	Memphis	Tennessee
United States	Solaris Clinical Research /ID# 216772	Meridian	Idaho
United States	Care Research center Inc. /ID# 216367	Miami	Florida
United States	Pharmax Research Clinic /ID# 216343	Miami	Florida
United States	Virginia Research Center /ID# 216341	Midlothian	Virginia
United States	Lucas Research /ID# 216487	Morehead City	North Carolina
United States	NewportNativeMD, Inc. /ID# 216992	Newport Beach	California
United States	Intend Research /ID# 216320	Norman	Oklahoma
United States	Valley Renal Medical Group Research /ID# 216321	Northridge	California
United States	Affinity Clinical Research /ID# 216807	Oak Brook	Illinois
United States	West Orange Endocrinology /ID# 217106	Ocoee	Florida
United States	Tristar Clinical Investigations PC /ID# 216944	Philadelphia	Pennsylvania
United States	Discovery Clinical Trials-San Antonio /ID# 216866	San Antonio	Texas
United States	West Coast Research LLC /ID# 216813	San Ramon	California
United States	Frontier Clinical Research /ID# 216365	Smithfield	Pennsylvania
United States	Northwest Houston Clinical Research PLLC /ID# 216358	Tomball	Texas
United States	Amici Clinical Research /ID# 216779	Warren	New Jersey
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	North Georgia Clinical Research /ID# 216864	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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