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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04682353 | A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age | PHASE1 | COMPLETED | 60 | — | — | Dec 14, 2020 | Jan 12, 2023 | Feb 26, 2024 | 3 | United States, Dominican Republic |
| NCT03700658 | A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046 | PHASE1 | COMPLETED | 27 | — | — | Jan 15, 2019 | Oct 2, 2020 | Jan 26, 2022 | 1 | Dominican Republic |
ISRs were assessed by self-reports and direct observation for each injection at least twice on the day of injection. ISRs included erythema (redness), swelling, pruritus (itching), bleeding, bruising, injection site discoloration (for example, hypopigmentation), or atrophy (that is, dimple).
| Arm | Type | Description |
|---|---|---|
| Group 1 - 120 mg/0.4 mL | EXPERIMENTAL | - |
| Group 2 - 180 mg/0.6 mL | EXPERIMENTAL | - |
| Group 3 - 240 mg/0.8 mL | EXPERIMENTAL | - |
| Group 4 - 104 mg/0.65 mL | ACTIVE_COMPARATOR | - |
| TV-46046 Undiluted | EXPERIMENTAL | Participants will receive TV-46046 undiluted (120 mg/0.3 mL of 400 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| TV-46046 Diluted | EXPERIMENTAL | Participants will receive TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| TV-46046 Placebo | PLACEBO_COMPARATOR | Participants will receive TV-46046 placebo (0.3 mL) SC injection in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| Depo-subQ 104 | ACTIVE_COMPARATOR | Participants will receive Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation in a crossover design with the other 3 SC study drug injections. The 4 study drug injections will be administered approximately 1 hour apart. |
| Name | Type | Description |
|---|---|---|
| TV-46046 | DRUG | SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL) |
| Depo-subQ Provera | DRUG | SC injection of 104 mg/0.65 mL |
| Depo-subQ 104 | DRUG | Depo-subQ 104 will be administered per dose and schedule specified in the arm. |
| TV-46046 Placebo | DRUG | TV-46046 Placebo will be administered per schedule specified in the arm. |
Inclusion Criteria: * has regular menstrual cycle (21 to 35 days) * has a low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, abstinent, in monogamous relationship with vasectomized partner, using nonhormonal intrauterine device (IUD), or consistently using barrier methods o...