A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
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
1 other identifier
interventional
168
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2020
Shorter than P25 for phase_4
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedStudy Start
First participant enrolled
May 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2021
CompletedResults Posted
Study results publicly available
July 12, 2022
CompletedJuly 12, 2022
June 1, 2022
1.1 years
March 23, 2020
June 17, 2022
June 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at 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.
Baseline and Week 16
Secondary Outcomes (4)
Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16
Baseline and Week 16
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16
Baseline and Week 16
Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16
Baseline and Week 16
Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16
Baseline and Week 16
Study Arms (1)
Androderm® 4 mg
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (41)
Central Research Associates, Inc.
Birmingham, Alabama, 35205, United States
Coastal Clinical Research, LLC, An AMR Co.
Mobile, Alabama, 36608, United States
Urological Associates of South Arizona, PC
Tucson, Arizona, 85712, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
San Diego Clinical Trials
La Mesa, California, 91942, United States
Wr-McCr, Llc
San Diego, California, 92103, United States
Care Access Research
Santa Clarita, California, 91321, United States
Creekside Endocrine Associates, PC
Denver, Colorado, 80246, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Ovieo Medical Research, LLC
Oviedo, Florida, 32765, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Precision Clinical Research, LLC
Sunrise, Florida, 33351, United States
Florida Urology Partners
Tampa, Florida, 33615, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Physicians Research Associates, LLC
Lawrenceville, Georgia, 30046, United States
Endocrine Consultants Newnan
Newnan, Georgia, 30265, United States
Idoho Urologic Institute
Meridian, Idaho, 83642, United States
The Iowa Clinic
West Des Moines, Iowa, 50266, United States
DelRicht Research, LLC
New Orleans, Louisiana, 70115, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Bay State Clinical Trials, Inc
Watertown, Massachusetts, 02427, United States
WR - Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, 89113, United States
Premier Urology Group
Edison, New Jersey, 08837, United States
AccuMed Research Associates
Garden City, New York, 11530, United States
Manhattan Medical Research Practice, PLLC
New York, New York, 10016, United States
Associated Urologist of North Carolina
Raleigh, North Carolina, 27612, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Texas Diabetes & Endocrinology
Austin, Texas, 78731, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749, United States
Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, 79935, United States
SMS Clinical Research, LLC2
Mesquite, Texas, 75149, United States
AIM Trials, LLC
Plano, Texas, 75093, United States
Texas Diabetes & Endocrinology
Round Rock, Texas, 78681, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229, United States
Virginia Urology
Richmond, Virginia, 23235, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
Rainier Clinical Research Center, Inc
Renton, Washington, 98057, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
Anna Chan
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 25, 2020
Study Start
May 19, 2020
Primary Completion
June 24, 2021
Study Completion
June 24, 2021
Last Updated
July 12, 2022
Results First Posted
July 12, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.