Study to Determine the Effects of Testosterone Replacemen... | NCT00161304

Studies
Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency

NCT00161304

Sponsor

Leonard S. Marks, M.D.

Status

Completed

Last Update Posted

Apr 28, 2021Actual

Enrollment

44Actual

Phase

Phase 2Phase 3

Conditions

Men With Low Testosterone Levels

Interventions

Testosterone Enanthate
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003Actual

Primary Completion Date

Aug 2004Actual

Completion Date

Nov 2004Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2021

Last Update Posted Date

Apr 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leonard S. Marks, M.D., Principal Investigator, Urological Sciences Research FoundationSponsor-Investigator

Lead Sponsor

Leonard S. Marks, M.D.OTHER

Collaborators

Name	Class
Solvay Pharmaceuticals	INDUSTRY
Watson Pharmaceuticals	INDUSTRY

Description Module

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.

Detailed Description

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. The primary objectives of the study are to measure the changes in tissue hormones and other biomarkers in the prostate tissue specimens.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Testosterone Enanthate	Active Comparator	Testosterone	Drug: Testosterone Enanthate
Placebo	Placebo Comparator	Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Testosterone Enanthate	Drug	Testosterone Enanthate	Testosterone Enanthate

Eligibility Module

Eligibility Criteria

The screening evaluation consisted of:

medical history, which included the androgen deficiency of the aging male questionnaire
physical examination
multiphasic serum panel
measurement of total serum testosterone and PSA levels

Exclusion criteria included:

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonard S Marks, M.D.	Urological Sciences Research Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urological Sciences Research Foundation		Culver City	California	90232	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17105798	Derived	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.

ID	Term
C004648	testosterone enanthate
D013739	Testosterone

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473