Status:
COMPLETED
A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
Lead Sponsor:
Allergan
Conditions:
Hypogonadism
Eligibility:
MALE
18-80 years
Phase:
PHASE4
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
- 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
- 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
Key Trial Info
Start Date :
May 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2021
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04320745
Start Date
May 19 2020
End Date
June 24 2021
Last Update
July 12 2022
Active Locations (41)
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1
Central Research Associates, Inc.
Birmingham, Alabama, United States, 35205
2
Coastal Clinical Research, LLC, An AMR Co.
Mobile, Alabama, United States, 36608
3
Urological Associates of South Arizona, PC
Tucson, Arizona, United States, 85712
4
Hope Clinical Research
Canoga Park, California, United States, 91303