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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320745
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Androderm® Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 19, 2020
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2021


Arm Intervention/treatment
Experimental: Androderm®
All participants to receive standard dose of Androderm of 4 mg/day applied nightly on Visit 1. At Visit 2 testosterone concentration will be measured.
Drug: Androderm®
Nightly Transdermal dose of Androderm® of either 2 mg/day, 4 mg/day, or 6 mg/day.




Primary Outcome Measures :
  1. Change from baseline in 24-hour average systolic blood pressure (SBP) obtained at Week 16 [ Time Frame: At Week 16 ]

Secondary Outcome Measures :
  1. Change from baseline in 24-hour average diastolic blood pressure (DBP) obtained at Week 16 [ Time Frame: At Week 16 ]
  2. Change from baseline in 24-hour average mean arterial pressure (MAP) obtained at Week 16 [ Time Frame: At Week 16 ]
  3. Change from baseline in 24-hour average pulse pressure obtained at Week 16 [ Time Frame: At Week 16 ]
  4. Change from baseline in 24-hour average heart rate obtained at Week 16 [ Time Frame: At Week 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and 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
  • BMI < 35 kg/m2
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320745


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Anna Chan Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04320745    
Other Study ID Numbers: 3146-402-016
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs