Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Etonogestrel-releasing IUS · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ENG-MIUS low | EXPERIMENTAL | Low dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm |
| ENG-MIUS intermediate | EXPERIMENTAL | Intermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm |
| ENG-MIUS high | EXPERIMENTAL | High dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm |
| Multiload | ACTIVE_COMPARATOR | Multiload-cu 375® |
| Name | Type | Description |
|---|---|---|
| Etonogestrel-releasing IUS | DRUG | Low dose; treatment duration of 6 months with a possible extension to 12 months |
| Multiload-cu 375® | DEVICE | Duration of 6 months with a possible extension to 12 months |
Inclusion Criteria: * Healthy female subjects in need for contraception will be selected to participate in the trial; * Each subject must be \>=18 to \<=40 years of age at screening and in need for contraception; * Each subject must have given birth to at least one child (gestational age \>=28 week...
Etonogestrel-releasing IUS is an investigational intrauterine system being studied for contraception. It is a small molecule product in Phase 2 clinical development, evaluated in a completed trial that assessed safety, acceptability, and vaginal bleeding patterns in healthy female volunteers.
Etonogestrel-releasing IUS is being developed by Organon & Co., a company traded under the ticker OGN. The product is currently in Phase 2 clinical development for contraception.
Etonogestrel-releasing IUS is in Phase 2 clinical development. It is an investigational product, not yet approved, and has completed one Phase 2 trial focused on contraception.
Etonogestrel-releasing IUS has one completed clinical trial, NCT00967746, titled "An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)." The trial enrolled 84 female participants in Germany.
Etonogestrel-releasing IUS is not FDA approved. It is an investigational product currently in Phase 2 clinical development for contraception, with one completed clinical trial.