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etonogestrel with testosterone undecanoate

Phase 2

Contraception | Small molecule | Other |Organon & Co.|Last Updated: Feb 4, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment350
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00403793Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)PHASE2 COMPLETED 350Oct 1, 2003Dec 1, 2006Feb 4, 2022 -
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Study Endpoints
Primary Endpoints
% of men who had a sperm concentration of 1 million/ml or less at week 16.
Week 16
Secondary Endpoints
Semen Parameters
At several timepoints during treatment
Reversibility of Suppression
Post-Treatment
Hormones
At several timepoints
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Arm 1ACTIVE_COMPARATORetonogestrel with testosterone undecanoate
Arm 2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
etonogestrel with testosterone undecanoateDRUG42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks
PlaceboDRUG42 or 44 weeks with placebo implant and placebo injections
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes

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, cardiovascu...

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