Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00403793

Collaborator

Bayer (Industry)

350

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: etonogestrel with testosterone undecanoate Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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

Study Start Date :

Oct 1, 2003

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 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
Placebo Comparator: Arm 2 Placebo	Drug: Placebo 42 or 44 weeks with placebo implant and placebo injections

Arm

Intervention/Treatment

Active Comparator: Arm 1

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

Placebo Comparator: Arm 2

Placebo

Drug: Placebo

42 or 44 weeks with placebo implant and placebo injections

Outcome Measures

Primary Outcome Measures

% of men who had a sperm concentration of 1 million/ml or less at week 16. [Week 16]

Secondary Outcome Measures

Semen Parameters [At several timepoints during treatment]
Reversibility of Suppression [Post-Treatment]
Hormones [At several timepoints]
Pharmacokinetics [At several timepoints]
Safety [At several timepoints]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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