A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
- Registration Number
- NCT04320745
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 168
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Androderm® 4 mg Androderm® Participants received Androderm® 4 mg, transdermal dose, once daily (QD) for up to 16 weeks. At Day 14, if serum concentration was less than 400 nanograms per deciliter (ng/dL), the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
- Primary Outcome Measures
Name Time Method Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16 Baseline and Week 16 SBP was collected by 24-hour ambulatory blood pressure monitoring (ABPM) device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
- Secondary Outcome Measures
Name Time Method Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16 Baseline and Week 16 DBP was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16 Baseline and Week 16 MAP was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16 Baseline and Week 16 Pulse pressure was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16 Baseline and Week 16 Heart rate was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
Trial Locations
- Locations (40)
Coastal Clinical Research, LLC, An AMR Co.
🇺🇸Mobile, Alabama, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Associated Urologist of North Carolina
🇺🇸Raleigh, North Carolina, United States
WR - Clinical Research Center of Nevada, LLC
🇺🇸Las Vegas, Nevada, United States
Diabetes & Glandular Disease Clinic, P.A.
🇺🇸San Antonio, Texas, United States
Central Research Associates, Inc.
🇺🇸Birmingham, Alabama, United States
Care Access Research
🇺🇸Santa Clarita, California, United States
Wr-McCr, Llc
🇺🇸San Diego, California, United States
Creekside Endocrine Associates, PC
🇺🇸Denver, Colorado, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Urological Associates of South Arizona, PC
🇺🇸Tucson, Arizona, United States
San Diego Clinical Trials
🇺🇸La Mesa, California, United States
Idoho Urologic Institute
🇺🇸Meridian, Idaho, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Physicians Research Associates, LLC
🇺🇸Lawrenceville, Georgia, United States
Ovieo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Premier Urology Group
🇺🇸Edison, New Jersey, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States
DelRicht Research, LLC
🇺🇸New Orleans, Louisiana, United States
MidLantic Urology
🇺🇸Bala-Cynwyd, Pennsylvania, United States
AIM Trials, LLC
🇺🇸Plano, Texas, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States
Rainier Clinical Research Center, Inc
🇺🇸Renton, Washington, United States
Texas Diabetes & Endocrinology
🇺🇸Round Rock, Texas, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
Precision Clinical Research, LLC
🇺🇸Sunrise, Florida, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Florida Urology Partners
🇺🇸Tampa, Florida, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Bay State Clinical Trials, Inc
🇺🇸Watertown, Massachusetts, United States
SMS Clinical Research, LLC2
🇺🇸Mesquite, Texas, United States
Manhattan Medical Research Practice, PLLC
🇺🇸New York, New York, United States
Academy of Diabetes Thyroid and Endocrine
🇺🇸El Paso, Texas, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Endocrine Consultants Newnan
🇺🇸Newnan, Georgia, United States
The Iowa Clinic
🇺🇸West Des Moines, Iowa, United States