Three-Year Trial on a New Testosterone Gel | NCT00204269

Studies
Three-Year Trial on a New Testosterone Gel

NCT00204269

Sponsor

University Hospital Muenster

Status

Unknown status

Last Update Posted

May 15, 2006Estimated

Enrollment

100

Phase

Phase 3

Conditions

Hypogonadism

Interventions

Testosterone Gel Wolff

Countries

Germany

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

ID	Type	Description	Link
TGT-04/2002

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 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

May 12, 2006

Last Update Posted Date

May 15, 2006Estimated

Name	Class
Dr. August Wolff GmbH & Co. KG Arzneimittel	INDUSTRY

Description Module

Brief Summary

The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff.

Detailed Description

A minimum of 100 patients will be recruited and evenly distributed to two treatment arms. 1st arm: dermal (non-scrotal) application of TGW. 2nd arm: scrotal application of TGW.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
Testosterone Gel Wolff	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
testosterone levels

Secondary Outcomes

Measure	Description	Time Frame
hormones
sexual function and mood disorder (questionnaire)
compliance (drug accountability)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men with

hypergonadotropic hypogonadism
hypogonadotropic hypogonadism
late-onset hypogonadism

combined with an initial Testosterone serum level of < 11 nmol/l

Exclusion Criteria:

known or suspected carcinoma of the prostate
clinically relevant abnormalities in clinical chemistry or haematology
any severe medical conditions at the opinion of the investigator

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Eberhard Nieschlag, Prof. Dr.	Institute of Reproductive Medicine of the University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic Charité, Division of Urology		Berlin		10117	Germany
Franziskus-Hospital, Division of Urology

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16061839	Background	Kuhnert B, Byrne M, Simoni M, Kopcke W, Gerss J, Lemmnitz G, Nieschlag E. Testosterone substitution with a new transdermal, hydroalcoholic gel applied to scrotal or non-scrotal skin: a multicentre trial. Eur J Endocrinol. 2005 Aug;153(2):317-26. doi: 10.1530/eje.1.01964.

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases