Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00967746 | An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060) | PHASE2 | COMPLETED | 84 | — | — | Nov 1, 2009 | Jul 1, 2011 | Apr 8, 2026 | 1 | Germany |
| 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...