Contraception in Normal and Subnormal Men | NCT00167141

Studies
Contraception in Normal and Subnormal Men

NCT00167141

Sponsor

University Hospital Muenster

Status

Terminated

Last Update Posted

Feb 2, 2010Estimated

Enrollment

41Actual

Phase

Phase 2

Conditions

Healthy

Interventions

injection of hormonal male contraceptive

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
IRM 2003/21

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Jan 2008Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 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

Feb 1, 2010

Last Update Posted Date

Feb 2, 2010Estimated

Description Module

Brief Summary

Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis.

Detailed Description

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

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
testosterone injections	Experimental	injections of testosterone to normal men (arm 1) and two men with subnormal semen parameters (arm 2)	Drug: injection of hormonal male contraceptive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
injection of hormonal male contraceptive	Drug	testosterone injections 4 times	testosterone injections

Measure	Description	Time Frame
semen parameters		2005 - 2008

Measure	Description	Time Frame
hormones		2005 2008

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Volunteers with normal and subnormal semen parameters

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Dr. Eberhard Nieschlag		Münster		48149	Germany