A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants

Completed · Phase 4

Conditions studied: Hypogonadism

In brief

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.

Key facts

Study ID

NCT04320745

Run by

Allergan

People needed

168

Starts

2020-05-19

Expected to finish

2021-06-24

Last updated by the study team

2022-07-12

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central Research Associates, Inc. — Birmingham, Alabama, United States
• Coastal Clinical Research, LLC, An AMR Co. — Mobile, Alabama, United States
• Urological Associates of South Arizona, PC — Tucson, Arizona, United States
• Hope Clinical Research — Canoga Park, California, United States
• Marvel Clinical Research — Huntington Beach, California, United States
• San Diego Clinical Trials — La Mesa, California, United States
• Wr-McCr, Llc — San Diego, California, United States
• Care Access Research — Santa Clarita, California, United States
• Creekside Endocrine Associates, PC — Denver, Colorado, United States
• South Florida Medical Research — Aventura, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Ovieo Medical Research, LLC — Oviedo, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Precision Clinical Research, LLC — Sunrise, Florida, United States
• Florida Urology Partners — Tampa, Florida, United States
• Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Physicians Research Associates, LLC — Lawrenceville, Georgia, United States
• Endocrine Consultants Newnan — Newnan, Georgia, United States
• Idoho Urologic Institute — Meridian, Idaho, United States
• The Iowa Clinic — West Des Moines, Iowa, United States
• DelRicht Research, LLC — New Orleans, Louisiana, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• Bay State Clinical Trials, Inc — Watertown, Massachusetts, United States

Full record on ClinicalTrials.gov

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