Hormonal Contraception in Healthy Young Men

Condition(s) targeted: Healthy

Intervention: etonogestrel with testosterone undecanoate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Organon

Official(s) and/or principal investigator(s):
Ellen Mommers, PhD, Study Director, Affiliation: NV Organon

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.

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 design: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: % of men who had a sperm concentration of 1 million/ml or less at week 16.

Secondary outcome:

semen parameters

reversibility of suppression

hormones

pharmacokinetics

safety

Detailed description: Male volunteers are treated for 42 or 44 weeks with a male contraceptive to investigate the suppression of sperm production. After end of treatment, they are followed for 24 weeks to evaluate the return of sperm counts. To evaluate the safety of the drug in more detail, a placebo group is included in the trial.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male

- Mentally and physically healthy

- BMI between 18 and 32 kg/m2

- 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

Organon Investigational Site, Turku, Finland

Organon Investigational Site, Nijmegen, Netherlands

Organon Investigational Site, Herlev, Denmark

Organon Investigational Site, Manchester, United Kingdom

Organon Investigational Site, Bologna, Italy

Organon Investigational Site, Berlin, Germany

Organon Investigational Site, Helsinki, Finland

Organon Investigational Site, Muenster, Germany

Organon Investigational Site, Halle, Germany

Organon Investigational Site, London, United Kingdom

Starting date: December 2003
Ending date: January 2006
Last updated: November 24, 2006