Pharmacokinetics of Testosterone Lotion in the Treatment... | NCT00372008

Studies
Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

NCT00372008

Sponsor

Acrux DDS Pty Ltd

Status

Completed

Last Update Posted

Jun 20, 2008Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Hypogonadism

Interventions

Testosterone

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

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Sep 5, 2006

First Submission Date that Met QC Criteria

Sep 5, 2006

First Posted Date

Sep 6, 2006Estimated

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

Jun 18, 2008

Last Update Posted Date

Jun 20, 2008Estimated

Description Module

Brief Summary

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Testosterone	Drug

Measure	Description	Time Frame
Pharmacokinetic

Measure	Description	Time Frame
Safety and tolerability

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hypogonadal males between 18-70 years old with qualifying general medical health

Exclusion Criteria:

Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Tina Soulis, PhD	Acrux Ltd	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham		Birmingham	Alabama		United States

Condition Browse Module

MeSH Terms

ID	Term
D007006	Hypogonadism

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013739	Testosterone

Ancestor Terms

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided