Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED) - Tabular View

Tracking Information
First Received Date ^ICMJE	November 22, 2006
Last Updated Date	October 2, 2009
Start Date ^ICMJE	December 2003
Primary Completion Date	January 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 8, 2008)	% of men who had a sperm concentration of 1 million/ml or less at week 16. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: November 24, 2006)	% of men who had a sperm concentration of 1 million/ml or less at week 16.
Change History	Complete list of historical versions of study NCT00403793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 8, 2008)	Semen Parameters [ Time Frame: At several timepoints during treatment ] [ Designated as safety issue: No ] Reversibility of Suppression [ Time Frame: Post-Treatment ] [ Designated as safety issue: Yes ] Hormones [ Time Frame: At several timepoints ] [ Designated as safety issue: No ] Pharmacokinetics [ Time Frame: At several timepoints ] [ Designated as safety issue: No ] Safety [ Time Frame: At several timepoints ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: November 24, 2006)	semen parameters reversibility of suppression hormones pharmacokinetics safety

Descriptive Information
Brief Title ^ICMJE	Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)
Official Title ^ICMJE	A Phase II -b, Placebo-Controlled Trial Investigating the Efficacy, Safety and Pharmacokinetics of a Subcutaneous Etonogestrel Implant Combined With i.m. Testosterone Undecanoate for Male Contraception
Brief Summary	Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a hormone and hormone injections in order to investigate the suppressive effect on sperm production and reversibility of sperm production after end of treatment.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Contraception
Intervention ^ICMJE	Drug: etonogestrel with testosterone undecanoate Drug: Placebo
Study Arms / Comparison Groups	Active Comparator: etonogestrel with testosterone undecanoate Placebo Comparator: Placebo
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	350
Completion Date	January 2006
Primary Completion Date	January 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male Mentally and physically healthy BMI between 18 and 32 kg/m^2 Two pre-treatment semen samples > 20 million/ml with normal morphology and motility Exclusion Criteria: History or presence of psychiatric disease, liver disease, renal disease, diabetes, cardiovascular disease, any malignancy, prostatic disease, or genitourinary infection PSA > 2.5 ng/ml Use of drugs known to interfere with pharmacokinetics of steroids Use of lipid-lowering drugs
Gender	Male
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00403793
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	P42306
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Bayer
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP