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

Sponsor:	Schering-Plough
Collaborator:	Bayer
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00403793

Purpose

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.

Condition	Intervention	Phase
Contraception	Drug: etonogestrel with testosterone undecanoate Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Etonogestrel Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

% 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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	350
Study Start Date:	December 2003
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator etonogestrel with testosterone undecanoate	Drug: etonogestrel with testosterone undecanoate 42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks
Arm 2: Placebo Comparator Placebo	Drug: Placebo 42 or 44 weeks with placebo implant and placebo injections

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P42306
Study First Received:	November 22, 2006
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00403793 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; Italy: The Italian Medicines Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Methyltestosterone

Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Testosterone
Anabolic Agents
Therapeutic Uses
3-keto-desogestrel
Androgens

ClinicalTrials.gov processed this record on November 27, 2009