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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403793
• Other study ID #: P06057
• Status: Completed
• Phase: Phase 2
• Start date: October 2003
• Est. completion date: December 2006

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• etonogestrel with testosterone undecanoate
42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks
• Placebo
42 or 44 weeks with placebo implant and placebo injections

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Bayer

References & Publications (1)

Mommers E, Kersemaekers WM, Elliesen J, Kepers M, Apter D, Behre HM, Beynon J, Bouloux PM, Costantino A, Gerbershagen HP, Grønlund L, Heger-Mahn D, Huhtaniemi I, Koldewijn EL, Lange C, Lindenberg S, Meriggiola MC, Meuleman E, Mulders PF, Nieschlag E, Perh — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of men who had a sperm concentration of 1 million/ml or less at week 16.		Week 16
Secondary	Semen Parameters		At several timepoints during treatment
Secondary	Reversibility of Suppression		Post-Treatment
Secondary	Hormones		At several timepoints
Secondary	Pharmacokinetics		At several timepoints
Secondary	Safety		At several timepoints