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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02817464 | Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle | PHASE1 | COMPLETED | 12 | — | — | Oct 26, 2016 | Dec 3, 2018 | Feb 12, 2024 | 2 | United States |
'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL.
| Arm | Type | Description |
|---|---|---|
| TV-46046 - 1 | EXPERIMENTAL | - |
| TV-46046 - 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TV-46046 - 400 mg/mL | DRUG | A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL |
| TV-46046 - 200 mg/mL | DRUG | A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/mL |
Inclusion Criteria: * has regular menstrual cycle (24 to 35 days) * is at low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, in monogamous relationship with vasectomized partner, or using non-hormonal IUD) * is in good general health as determined by a medical history and p...