Observation Study of T-Gel (1%) in Treatment of Adolescen... | NCT00193661 | Trialant

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Observation Study of T-Gel (1%) in Treatment of Adolescen... | NCT00193661 | Trialant

Studies
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism

NCT00193661

Sponsor

Solvay Pharmaceuticals

Status

Completed

Last Update Posted

Jan 16, 2015Estimated

Enrollment

Not provided

Phase

Phase 2

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

NCT00193661

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

UMD-01-090

Secondary IDs

Not provided

Brief Title

Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism

Official Title

A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism

Acronym

Not provided

Organization

Solvay PharmaceuticalsINDUSTRY

Status Module

Record Verification Date

Sep 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

Mar 2007Actual

Completion Date

Mar 2007Actual

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

Jan 15, 2015

Last Update Posted Date

Jan 16, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Solvay PharmaceuticalsINDUSTRY

Collaborators

Name	Class
Unimed Pharmaceuticals	INDUSTRY

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).

Detailed Description

Not provided

Conditions Module

Conditions

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

Keywords

Hypogonadism

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

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

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

Outcomes Module

No data available

No data is available for this block.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

Exclusion Criteria:

Skin intolerance to alcohol or allergy to soy
Generalized skin disease
Contraindication to testosterone or androgen products

Accepts Healthy Volunteers

No

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 130		Birmingham	Alabama		United States
Site 107

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Non-Randomized

Intervention Model

Single Group Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

Los Angeles

California

United States

Site 113

Sacramento

California

United States

Site 114

Torrance

California

United States

Site 121

Gainesville

Florida

United States

Site 127

Jacksonville

Florida

United States

Site 128

Jacksonville

Florida

United States

Site 117

Indianapolis

Indiana

United States

Site 111

Kansas City

Missouri

United States

Site 129

Brooklyn

New York

United States

Site 123

New York

New York

United States

Site 131

Cincinnati

Ohio

United States

Site 124

Columbus

Ohio

United States

Site 103

Portland

Oregon

United States

Site 109

Hershey

Pennsylvania

United States

Site 125

Philadelphia

Pennsylvania

United States

Site 126

Philadelphia

Pennsylvania

United States

Site 104

Memphis

Tennessee

United States

Site 205

Seattle

Washington

United States

ID	Term
D007006	Hypogonadism

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided