NCT01377103

Brief Summary

The purpose of this study is to evaluate whether benefits of topical testosterone on symptoms and function of male HF patients, and its effects on rehospitalization rates and quality of life.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable heart-failure

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 19, 2017

Status Verified

April 1, 2011

Enrollment Period

1.3 years

First QC Date

May 18, 2011

Last Update Submit

July 14, 2017

Conditions

Heart FailureHypogonadism

Keywords

heart failurehypogonadismtestosterone

Outcome Measures

Primary Outcomes (3)

  • heart failure outcomes

    rehospitalization rates, mortality, New York Heart Association class and symptomatolgy

    16 months

  • depression and mood

    Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression

    16 months

  • quality of life

    Minnesota Living with Heart Failure Questionnaire

    16 months

Secondary Outcomes (3)

  • overall satisfaction

    16 months

  • compliance

    16 months

  • markers for heart failure

    16 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Gel

Drug: Placebo

Testosterone Supplementation

ACTIVE COMPARATOR

Testosterone Gel

Drug: testerone gel

Interventions

testerone gelDRUG

5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel

Also known as: AndroGel(R)
Testosterone Supplementation
PlaceboDRUG
Placebo

Eligibility Criteria

Age36 Years - 79 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male
  • NYHA class II-IV Heart Failure
  • age \> 35 \< 80
  • total testosterone level of \<5 ng/ml

You may not qualify if:

  • elevated prostate specific antigen
  • elevated total or free testosterone level
  • prostate cancer or evidence of symptomatic prostatism
  • untreated prolactinemia or history of breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart FailureHypogonadism

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ernst Schwarz, MD, PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliate, Cedars-Sinai Heart Institute

Study Record Dates

First Submitted

May 18, 2011

First Posted

June 21, 2011

Study Start

July 1, 2011

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

July 19, 2017

Record last verified: 2011-04