Clinical trial NCT04320745: A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
Official title: A Phase IV, Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of 16 Weeks Treatment With Androderm® in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadism
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-03-25
Enrollment: 168
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of a once daily Androderm® dose on Blood Pressure (BP) in adult hypogonadal men as measured by 24-hour ABPM.


Eligibility criteria: Inclusion Criteria:

* Naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and dehydroepiandrosterone (DHEA), including investigational products that may affect the reproductive hormonal system or has not been treated with these compounds in the past 6 months
* Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
* Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
* Body mass index (BMI) \< 35 kilograms per metre square (kg/m\^2)
* Male

Exclusion Criteria:

* Uncontrolled systemic disease or clinically significant disease, in particular, liver, kidney or heart disease, including hypertension, congestive heart failure, coronary heart disease, chronic atrial fibrillation, sleep apnea or psychiatric illness, that in the investigator's opinion, would put the participant at an unacceptable risk with exposure to Androderm®
* History of prostate (current or in the past) or breast cancer
* Had a recent (within 2 years) history of stroke, transient ischemic attack, acute coronary event, venous thrombotic, or thromboembolic event
* History of alcohol or other substance abuse within the previous 2 years
* Known allergy or sensitivity to the study intervention or its components or other testosterone replacement medications
* Participant who works night shifts or who will need to perform strenuous manual labor while wearing the ABPM monitor

Primary outcomes:
measure: Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc.
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, LLC, An AMR Co.
state: Alabama
city: Tucson
country: United States
facility: Urological Associates of South Arizona, PC
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: La Mesa
country: United States
facility: San Diego Clinical Trials
state: California
city: San Diego
country: United States
facility: Wr-McCr, Llc
state: California
city: Santa Clarita
country: United States
facility: Care Access Research
state: California
city: Denver
country: United States
facility: Creekside Endocrine Associates, PC
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Oviedo
country: United States
facility: Ovieo Medical Research, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Lawrenceville
country: United States
facility: Physicians Research Associates, LLC
state: Georgia
city: Newnan
country: United States
facility: Endocrine Consultants Newnan
state: Georgia
city: Meridian
country: United States
facility: Idoho Urologic Institute
state: Idaho
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: New Orleans
country: United States
facility: DelRicht Research, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc
state: Massachusetts
city: Las Vegas
country: United States
facility: WR - Clinical Research Center of Nevada, LLC
state: Nevada
city: Edison
country: United States
facility: Premier Urology Group
state: New Jersey
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice, PLLC
state: New York
city: Raleigh
country: United States
facility: Associated Urologist of North Carolina
state: North Carolina
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: El Paso
country: United States
facility: Academy of Diabetes Thyroid and Endocrine
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research, LLC2
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic, P.A.
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc
state: Washington
Study officials:
affiliation: Allergan
name: Anna Chan
role: STUDY_DIRECTOR
References: