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

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

MedlinePlus related topics:

Birth Control

ChemIDplus related topics:

Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Etonogestrel

U.S. FDA Resources

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

Further study details as provided by Organon:

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

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	P42306
First Received:	November 22, 2006
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00403793
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Italy: The Italian Medicines Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Testosterone

Desogestrel

Methyltestosterone

Healthy

3-keto-desogestrel

Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents

Antineoplastic Agents, Hormonal

Contraceptive Agents

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Contraceptive Agents, Female

Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents

Hormones

Pharmacologic Actions

Androgens

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	Organon Bayer Schering AG
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00403793