Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
etonogestrel with testosterone undecanoate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | etonogestrel with testosterone undecanoate |
| Arm 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| etonogestrel with testosterone undecanoate | DRUG | 42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks |
| Placebo | DRUG | 42 or 44 weeks with placebo implant and placebo injections |
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...
Etonogestrel with testosterone undecanoate is an investigational combination being studied for contraception in healthy young men. It is a small molecule product in Phase 2 clinical development. The combination is intended to provide hormonal contraception for males, though it is not yet approved and remains under investigation.
Organon & Co. (NYSE: OGN) is developing etonogestrel with testosterone undecanoate. The company is conducting clinical trials to evaluate this combination as a male contraceptive. The product is currently in Phase 2 development and is not yet approved for commercial use.
Etonogestrel with testosterone undecanoate is in Phase 2 clinical development. It is an investigational product being studied for contraception in men. The Phase 2 trial has been completed, and the product has not received regulatory approval. Further development stages have not been publicly disclosed.
Etonogestrel with testosterone undecanoate has one completed Phase 2 clinical trial, NCT00403793, titled 'Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)'. This randomized, double-blind, placebo-controlled trial enrolled 350 healthy male participants aged 18 years and older to evaluate the combination for contraception.
Etonogestrel with testosterone undecanoate is not FDA approved. It is an investigational combination currently in Phase 2 clinical development for male contraception. The completed Phase 2 trial, NCT00403793, evaluated its safety and efficacy, but the product has not received marketing authorization from the FDA or other regulatory agencies.