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A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men ( TRAVERSE ) (TRAVERSE)

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ClinicalTrials.gov Identifier: NCT03518034
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : July 15, 2019
Sponsor:
Collaborators:
Acerus Pharmaceuticals Corporation
Allergan Sales, LLC
Endo Pharmaceuticals
Upsher-Smith Laboratories
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 3, 2018
First Posted Date  ICMJE May 8, 2018
Last Update Posted Date July 15, 2019
Actual Study Start Date  ICMJE May 3, 2018
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
Time to Major Adverse Cardiac Event (MACE) [ Time Frame: Up to study completion (approximately month 60) ]
It is defined as time from randomization to first component event occurrence of the composite MACE endpoint. MACE is defined as a composite endpoint consisting of any of the following: nonfatal myocardial infarction (MI), nonfatal stroke or death due to cardiovascular (CV) causes.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03518034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
  • Assessing cardiovascular safety [ Time Frame: Up to study completion (approximately month 60) ]
    Cardiovascular safety is time from randomization to first component event occurrence of the composite endpoint consisting of the following: nonfatal MI, nonfatal stroke, death due to CV causes or cardiac revascularization procedures/ cardiac percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG).
  • Assessing prostate safety [ Time Frame: Up to study completion (approximately month 60) ]
    It is assessed by the incidence of high grade prostate cancer.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 3, 2018)
  • Change from Baseline in overall sexual activity per Psychosexual Daily Questionnaire (PDQ) [ Time Frame: From month 0 (baseline) to study completion (approximately month 60) ]
    Improvement in sexual activity in hypogonadal men with low libido will be assessed.
  • Proportion of men whose persistent depressive disorder (PDD) remits during intervention per remission definition [ Time Frame: Up to study completion (approximately month 60) ]
    Remission of depression in hypogonadal men with late-onset, low grade persistent depressive disorder (PDD) (dysthymia) will be assessed.
  • Proportion of men with bone fractures [ Time Frame: Up to study completion (approximately month 60) ]
    Reduction in incidence of clinical fractures will be assessed.
  • Proportion of anemic men whose anemia is corrected during the intervention period [ Time Frame: Up to study completion (approximately month 60) ]
    Correction of anemia in subset of participants with baseline anemia will be assessed.
  • Proportion of men, who had pre-diabetes at Baseline, and who progress to diabetes [ Time Frame: Up to study completion (approximately month 60) ]
    Reduction in progression from pre-diabetes to diabetes in subset of participants with pre-diabetes at baseline will be assessed.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men ( TRAVERSE )
Official Title  ICMJE Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study
Brief Summary This is a blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypogonadism
  • Cardiovascular Diseases
Intervention  ICMJE
  • Drug: Testosterone
    It will be administered topically.
    Other Name: Androgel®
  • Drug: Placebo
    A matching placebo to testosterone will be administered topically.
Study Arms  ICMJE
  • Active Comparator: Arm A
    Participants receiving topical testosterone
    Intervention: Drug: Testosterone
  • Placebo Comparator: Arm B
    Participants receiving placebo
    Intervention: Drug: Placebo
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: May 3, 2018)
6000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men between 45 and 80 years age
  • Participants with low serum testosterone concentrations (< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.

Exclusion Criteria:

  • Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
  • Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
  • Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
  • Confirmed testosterone < 100 ng/dL
  • Body Mass Index (BMI) > 50
  • Hemoglobin A1c (HbA1C) > 11%
  • Hematocrit (Hct) > 50%
  • Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
  • History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries American Samoa
 
Administrative Information
NCT Number  ICMJE NCT03518034
Other Study ID Numbers  ICMJE M16-100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE
  • Acerus Pharmaceuticals Corporation
  • Allergan Sales, LLC
  • Endo Pharmaceuticals
  • Upsher-Smith Laboratories
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date July 2019

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