Pharmacokinetic Evaluation of Testosterone Gel (1%) | NCT00193700

Studies
Pharmacokinetic Evaluation of Testosterone Gel (1%)

NCT00193700

Sponsor

Solvay Pharmaceuticals

Status

Completed

Last Update Posted

Dec 25, 2006Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Primary or Secondary Hypogonadism
Constitutional Delay in Growth and Puberty (CDGP)

Interventions

Testosterone Gel (1%)

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

Nov 2006

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

Aug 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 19, 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

Dec 23, 2006

Last Update Posted Date

Dec 25, 2006Estimated

Name	Class
Unimed Pharmaceuticals	INDUSTRY

Description Module

Brief Summary

Measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel. Subjects who complete this trial may participate in the extension part (UMD-01-080E).

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Testosterone Gel (1%)	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

Exclusion Criteria:

Clinically significant uncontrolled medical condition or psychiatric disorder

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Director Solvay	Solvay Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site 208		Birmingham	Alabama		United States
Site 203

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases