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

Organon

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Drug: etonogestrel with testosterone undecanoate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00403793

P06057

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

etonogestrel with testosterone undecanoate

Treatment:

Drug: etonogestrel with testosterone undecanoate

Arm 2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo