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

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Androderm®
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Central Research Associates, Inc.
  • Coastal Clinical Research, LLC, An AMR Co.
  • Urological Associates of South Arizona, PC
  • Hope Clinical Research
  • Marvel Clinical Research
  • San Diego Clinical Trials
  • Wr-McCr, Llc
  • Care Access Research
  • Creekside Endocrine Associates, PC
  • South Florida Medical Research
  • Renstar Medical Research
  • Ovieo Medical Research, LLC
  • Meridien Research
  • Precision Clinical Research, LLC
  • Florida Urology Partners
  • Metabolic Research Institute, Inc.
  • Atlanta Diabetes Associates
  • Columbus Regional Research Institute
  • Physicians Research Associates, LLC
  • Endocrine Consultants Newnan
  • Idoho Urologic Institute
  • The Iowa Clinic
  • DelRicht Research, LLC
  • Regional Urology, LLC
  • Bay State Clinical Trials, Inc
  • WR - Clinical Research Center of Nevada, LLC
  • Premier Urology Group
  • AccuMed Research Associates
  • Manhattan Medical Research Practice, PLLC
  • Associated Urologist of North Carolina
  • MidLantic Urology
  • Texas Diabetes & Endocrinology
  • Texas Diabetes & Endocrinology, P.A.
  • Academy of Diabetes Thyroid and Endocrine
  • SMS Clinical Research, LLC2
  • AIM Trials, LLC
  • Texas Diabetes & Endocrinology
  • Diabetes & Glandular Disease Clinic, P.A.
  • Virginia Urology
  • Urology of Virginia
  • Rainier Clinical Research Center, Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Androderm® 4 mg

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 23, 2020
Last Updated
June 17, 2022
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT04320745
Brief Title
A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
June 24, 2021 (Actual)
Study Completion Date
June 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Androderm® 4 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Androderm®
Intervention Description
Androderm® transdermal dose.
Primary Outcome Measure Information:
Title
Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16
Description
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.
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16
Description
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.
Time Frame
Baseline and Week 16

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Chan
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Coastal Clinical Research, LLC, An AMR Co.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Urological Associates of South Arizona, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Marvel Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
San Diego Clinical Trials
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Wr-McCr, Llc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Care Access Research
City
Santa Clarita
State/Province
California
ZIP/Postal Code
91321
Country
United States
Facility Name
Creekside Endocrine Associates, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Ovieo Medical Research, LLC
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Precision Clinical Research, LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Florida Urology Partners
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Physicians Research Associates, LLC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Endocrine Consultants Newnan
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Idoho Urologic Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
The Iowa Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
DelRicht Research, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Bay State Clinical Trials, Inc
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02427
Country
United States
Facility Name
WR - Clinical Research Center of Nevada, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Premier Urology Group
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Manhattan Medical Research Practice, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Associated Urologist of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Texas Diabetes & Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Academy of Diabetes Thyroid and Endocrine
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
SMS Clinical Research, LLC2
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
AIM Trials, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Texas Diabetes & Endocrinology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Diabetes & Glandular Disease Clinic, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Urology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Rainier Clinical Research Center, Inc
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://rxabbvie.com
Description
Related Info

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

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