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

Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320745
• Other study ID #: 3146-402-016
• Status: Completed
• Phase: Phase 4
• Start date: May 19, 2020
• Est. completion date: June 24, 2021

Study information

• Verified date: June 2022
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 24, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Androderm®
Androderm® transdermal dose.

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Texas Diabetes & Endocrinology	Austin	Texas
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	South Florida Medical Research	Aventura	Florida
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Central Research Associates, Inc.	Birmingham	Alabama
United States	Hope Clinical Research	Canoga Park	California
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Creekside Endocrine Associates, PC	Denver	Colorado
United States	Premier Urology Group	Edison	New Jersey
United States	Academy of Diabetes Thyroid and Endocrine	El Paso	Texas
United States	AccuMed Research Associates	Garden City	New York
United States	Marvel Clinical Research	Huntington Beach	California
United States	San Diego Clinical Trials	La Mesa	California
United States	WR - Clinical Research Center of Nevada, LLC	Las Vegas	Nevada
United States	Physicians Research Associates, LLC	Lawrenceville	Georgia
United States	Idoho Urologic Institute	Meridian	Idaho
United States	SMS Clinical Research, LLC2	Mesquite	Texas
United States	Coastal Clinical Research, LLC, An AMR Co.	Mobile	Alabama
United States	DelRicht Research, LLC	New Orleans	Louisiana
United States	Manhattan Medical Research Practice, PLLC	New York	New York
United States	Endocrine Consultants Newnan	Newnan	Georgia
United States	Renstar Medical Research	Ocala	Florida
United States	Ovieo Medical Research, LLC	Oviedo	Florida
United States	AIM Trials, LLC	Plano	Texas
United States	Associated Urologist of North Carolina	Raleigh	North Carolina
United States	Rainier Clinical Research Center, Inc	Renton	Washington
United States	Virginia Urology	Richmond	Virginia
United States	Texas Diabetes & Endocrinology	Round Rock	Texas
United States	Meridien Research	Saint Petersburg	Florida
United States	Diabetes & Glandular Disease Clinic, P.A.	San Antonio	Texas
United States	Wr-McCr, Llc	San Diego	California
United States	Care Access Research	Santa Clarita	California
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Precision Clinical Research, LLC	Sunrise	Florida
United States	Florida Urology Partners	Tampa	Florida
United States	Urological Associates of South Arizona, PC	Tucson	Arizona
United States	Urology of Virginia	Virginia Beach	Virginia
United States	Bay State Clinical Trials, Inc	Watertown	Massachusetts
United States	The Iowa Clinic	West Des Moines	Iowa
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and Week 16
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.	Baseline and Week 16
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.	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.	Baseline and Week 16
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.	Baseline and Week 16

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