NCT00161304

Brief Summary

The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

September 8, 2005

Last Update Submit

April 26, 2021

Conditions

Men With Low Testosterone Levels

Study Arms (2)

Testosterone Enanthate

ACTIVE COMPARATOR

Testosterone

Drug: Testosterone Enanthate

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Testosterone EnanthateDRUG

Testosterone Enanthate

Also known as: testosterone
Testosterone Enanthate
PlaceboOTHER

placebo

Placebo

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis
  • serum PSA level greater than 10.0 ng/mL
  • refusal or inability to undergo prostate biopsies
  • presence of prostate cancer on initial biopsy results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urological Sciences Research Foundation

Culver City, California, 90232, United States

Location

Related Publications (1)

  • Marks LS, Mazer NA, Mostaghel E, Hess DL, Dorey FJ, Epstein JI, Veltri RW, Makarov DV, Partin AW, Bostwick DG, Macairan ML, Nelson PS. Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2351-61. doi: 10.1001/jama.296.19.2351.

    PMID: 17105798DERIVED

Related Links

MeSH Terms

Interventions

testosterone enanthateTestosterone

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Leonard S Marks, M.D.

    Urological Sciences Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 1, 2003

Primary Completion

August 1, 2004

Study Completion

November 1, 2004

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

US(1)