NCT00167141

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2 healthy

Timeline
Completed

Started Feb 2005

Typical duration for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 2, 2010

Status Verified

March 1, 2007

Enrollment Period

2.8 years

First QC Date

September 6, 2005

Last Update Submit

February 1, 2010

Conditions

Healthy

Keywords

male fertilitysemen parameters

Outcome Measures

Primary Outcomes (1)

  • semen parameters

    2005 - 2008

Secondary Outcomes (1)

  • hormones

    2005 2008

Study Arms (1)

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

injection of hormonal male contraceptiveDRUG

testosterone injections 4 times

testosterone injections

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers with normal and subnormal semen parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Eberhard Nieschlag

Münster, 48149, Germany

Location

Study Officials

  • Eberhard Nieschlag, Prof. Dr.

    Institute of Reproductive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 14, 2005

Study Start

February 1, 2005

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

February 2, 2010

Record last verified: 2007-03

Locations

DE(1)