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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 : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE March 25, 2020
Last Update Posted Date December 7, 2020
Actual Study Start Date  ICMJE May 19, 2020
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
Change from baseline in 24-hour average systolic blood pressure (SBP) obtained at Week 16 [ Time Frame: At Week 16 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • Change from baseline in 24-hour average diastolic blood pressure (DBP) obtained at Week 16 [ Time Frame: At Week 16 ]
  • Change from baseline in 24-hour average mean arterial pressure (MAP) obtained at Week 16 [ Time Frame: At Week 16 ]
  • Change from baseline in 24-hour average pulse pressure obtained at Week 16 [ Time Frame: At Week 16 ]
  • Change from baseline in 24-hour average heart rate obtained at Week 16 [ Time Frame: At Week 16 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Androderm's Effect on Blood Pressure in Adult Hypogonodal Male Participants.
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypogonadism
Intervention  ICMJE Drug: Androderm®
Nightly Transdermal dose of Androderm® of either 2 mg/day, 4 mg/day, or 6 mg/day.
Study Arms  ICMJE 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.
Intervention: Drug: Androderm®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2021
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04320745
Other Study ID Numbers  ICMJE 3146-402-016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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/
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anna Chan Allergan
PRS Account Allergan
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP