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

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.

Study Overview

• Status: Completed
• Conditions: Hypogonadism
• Intervention / Treatment: Drug: Androderm®

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates, Inc.
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, LLC, An AMR Co.
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Urological Associates of South Arizona, PC
  • California
    • Canoga Park, California, United States, 91303
      • HOPE Clinical Research
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • La Mesa, California, United States, 91942
      • San Diego Clinical Trials
    • San Diego, California, United States, 92103
      • Wr-McCr, Llc
    • Santa Clarita, California, United States, 91321
      • Care Access Research
  • Colorado
    • Denver, Colorado, United States, 80246
      • Creekside Endocrine Associates, PC
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Oviedo, Florida, United States, 32765
      • Ovieo Medical Research, LLC
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research, LLC
    • Tampa, Florida, United States, 33615
      • Florida Urology Partners
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Lawrenceville, Georgia, United States, 30046
      • Physicians Research Associates, LLC
    • Newnan, Georgia, United States, 30265
      • Endocrine Consultants Newnan
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Idoho Urologic Institute
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research, LLC
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Massachusetts
    • Watertown, Massachusetts, United States, 02427
      • Bay State Clinical Trials, Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • WR - Clinical Research Center of Nevada, LLC
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Premier Urology Group
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • New York, New York, United States, 10016
      • Manhattan Medical Research Practice, PLLC
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologist of North Carolina
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Diabetes & Endocrinology, P.A.
    • Austin, Texas, United States, 78731
      • Texas Diabetes & Endocrinology
    • El Paso, Texas, United States, 79935
      • Academy of Diabetes Thyroid and Endocrine
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research, LLC2
    • Plano, Texas, United States, 75093
      • AIM Trials, LLC
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes & Endocrinology
    • San Antonio, Texas, United States, 78229
      • Diabetes & Glandular Disease Clinic, P.A.
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia Urology
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Androderm® 4 mg; 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.

Drug: Androderm®; Androderm® transdermal dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at 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.	Baseline and Week 16
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at 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.	Baseline and Week 16
Change From Baseline in 24-hour Average Pulse Pressure Obtained at 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.	Baseline and Week 16
Change From Baseline in 24-hour Average Heart Rate Obtained at 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.	Baseline and Week 16

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2020
• Primary Completion (ACTUAL): June 24, 2021
• Study Completion (ACTUAL): June 24, 2021

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (ACTUAL): March 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: 3146-402-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No