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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 : September 23, 2019
Sponsor:
Collaborators:
Acerus Pharmaceuticals Corporation
Allergan Sales, LLC
Endo Pharmaceuticals
Upsher-Smith Laboratories
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypogonadism Cardiovascular Diseases Drug: Testosterone Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A
Participants receiving topical testosterone
 Drug: Testosterone
It will be administered topically.
Other Name: Androgel®
Placebo Comparator: Arm B
Participants receiving placebo
 Drug: Placebo
A matching placebo to testosterone will be administered topically.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. Assessing prostate safety [ Time Frame: Up to study completion (approximately month 60) ]
    It is assessed by the incidence of high grade prostate cancer.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Proportion of men with bone fractures [ Time Frame: Up to study completion (approximately month 60) ]
    Reduction in incidence of clinical fractures will be assessed.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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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): NCT03518034


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Acerus Pharmaceuticals Corporation
Allergan Sales, LLC
Endo Pharmaceuticals
Upsher-Smith Laboratories
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03518034     History of Changes
Other Study ID Numbers: M16-100
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

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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
Keywords provided by AbbVie:
hypogonadism
cardiovascular (CV) disease
AndroGel
testosterone replacement therapy (TRT)
Additional relevant MeSH terms:
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Hypogonadism
Cardiovascular Diseases
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
 Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents