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

Organon and Co350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

350

Conditions

Contraception

Interventions

etonogestrel with testosterone undecanoateDRUG

42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks

PlaceboDRUG

42 or 44 weeks with placebo implant and placebo injections

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Week 16

Secondary Outcomes

Semen Parameters

Time frame: At several timepoints during treatment

Reversibility of Suppression

Time frame: Post-Treatment

Hormones

Time frame: At several timepoints

Pharmacokinetics

Time frame: At several timepoints

Safety

Time frame: At several timepoints

Data from ClinicalTrials.gov

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