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etonogestrel with testosterone undecanoate

Phase 2

Contraception | Small molecule | Endocrine |Organon & Co.|Trials Updated: Feb 4, 2022

etonogestrel with testosterone undecanoate development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2006

etonogestrel with testosterone undecanoate target and mechanism

Molecular targetPGR
Target classAgonist
ModalitySmall molecule

Also known as Etonogestrel (ENG), Etonogestrel

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment350

FDA Designations

No designations recorded

etonogestrel with testosterone undecanoate clinical trials

etonogestrel with testosterone undecanoate · 1 trial · 1 indication

Phase 2 1
NCT00403793Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)Contraception
COMPLETED350 Analytics
PHASE2COMPLETED
Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)
ContraceptionUnlock trial analytics

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 to 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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Frequently asked questions about etonogestrel with testosterone undecanoate

What is etonogestrel with testosterone undecanoate?

Etonogestrel with testosterone undecanoate is an investigational small molecule combination being studied for contraception in healthy young men. It pairs etonogestrel, a progestin, with testosterone undecanoate. Organon & Co. (ticker: OGN) is developing it, and it has completed a Phase 2 trial.

What is etonogestrel with testosterone undecanoate used for?

Etonogestrel with testosterone undecanoate is being developed for contraception. The completed Phase 2 trial enrolled healthy young men aged 18 years and older. It is not approved for any use and remains an investigational product.

What does etonogestrel with testosterone undecanoate target?

Etonogestrel with testosterone undecanoate targets the progesterone receptor (PGR) as an agonist. Etonogestrel acts as a progestin agonist at PGR, while testosterone undecanoate provides androgen. This combination is being studied for male contraception.

Who is developing etonogestrel with testosterone undecanoate?

Organon & Co. (ticker: OGN) is developing etonogestrel with testosterone undecanoate. The company is responsible for the clinical program, including the completed Phase 2 trial in healthy young men for contraception.

What phase is etonogestrel with testosterone undecanoate in?

Etonogestrel with testosterone undecanoate is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. It is investigational and has not been approved by the FDA.

What clinical trials is etonogestrel with testosterone undecanoate in?

Etonogestrel with testosterone undecanoate has been studied in one completed Phase 2 trial, NCT00403793, titled Hormonal Contraception in Healthy Young Men. The trial enrolled 350 participants, was randomized, double-blind, and placebo-controlled, and included healthy male volunteers aged 18 years and older.

Is etonogestrel with testosterone undecanoate the same as etonogestrel?

Etonogestrel with testosterone undecanoate is a combination product that includes etonogestrel, also known as ENG. Etonogestrel alone is a progestin used in other contraceptives, but this specific combination with testosterone undecanoate is a distinct investigational product developed by Organon.