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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Androderm® 4 mg | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Androderm® | Drug | Androderm® transdermal dose. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Chan | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates, Inc. | Birmingham | Alabama | 35205 | United States | ||
| Coastal Clinical Research, LLC, An AMR Co. |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
For details on when studies are available for sharing, please refer to the link below.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2019 | Jun 17, 2022 |
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| 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 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population included all treated participants who receive ≥ 1 administration of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Androderm® 4 mg | Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intent-to-treat (mITT) Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline and Week 16 |
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| Secondary | 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. | mITT Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 16 |
|
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| Secondary | 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. | mITT Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 16 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | mITT Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 16 |
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| Secondary | 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. | mITT Population included all participants with valid baseline ABPM session of SBP, who received ≥ 1 administration of study intervention, ≥ 1 post-treatment assessments of SBP, valid Week 16 ABPM session of SBP, and at least 85% compliance to study intervention for the duration of the study. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline and Week 16 |
|
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From first dose of study drug until end of study or early termination visit (up to approximately 16 weeks)
Safety Population included all treated participants who receive ≥ 1 administration of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Androderm® 4 mg | Participants received Androderm® 4 mg, transdermal dose, QD for up to 16 weeks. At Day 14, if serum concentration was less than 400 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. | 0 | 168 | 2 | 168 | 29 | 168 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BRADYCARDIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APPLICATION SITE ERYTHEMA | General disorders | MedDRA 24.0 | Systematic Assessment |
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| APPLICATION SITE RASH | General disorders | MedDRA 24.0 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2020 | Jun 17, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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