Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)
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
1 other identifier
interventional
350
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2003
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 22, 2006
CompletedFirst Posted
Study publicly available on registry
November 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFebruary 4, 2022
February 1, 2022
3.2 years
November 22, 2006
February 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
% of men who had a sperm concentration of 1 million/ml or less at week 16.
Week 16
Secondary Outcomes (5)
Semen Parameters
At several timepoints during treatment
Reversibility of Suppression
Post-Treatment
Hormones
At several timepoints
Pharmacokinetics
At several timepoints
Safety
At several timepoints
Study Arms (2)
Arm 1
ACTIVE COMPARATORetonogestrel with testosterone undecanoate
Arm 2
PLACEBO COMPARATORPlacebo
Interventions
42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
- Bayercollaborator
Related Publications (1)
Mommers E, Kersemaekers WM, Elliesen J, Kepers M, Apter D, Behre HM, Beynon J, Bouloux PM, Costantino A, Gerbershagen HP, Gronlund L, Heger-Mahn D, Huhtaniemi I, Koldewijn EL, Lange C, Lindenberg S, Meriggiola MC, Meuleman E, Mulders PF, Nieschlag E, Perheentupa A, Solomon A, Vaisala L, Wu FC, Zitzmann M. Male hormonal contraception: a double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2008 Jul;93(7):2572-80. doi: 10.1210/jc.2008-0265. Epub 2008 Apr 15.
PMID: 18413423RESULT
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2006
First Posted
November 27, 2006
Study Start
October 1, 2003
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
February 4, 2022
Record last verified: 2022-02