Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TV-46046-mL
TV-46046 · 3 trials · 2 indications
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).
'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 |
|---|---|---|
| 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. |
| TV-46046 - 1 | EXPERIMENTAL | - |
| TV-46046 - 2 | EXPERIMENTAL | - |
| 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. |
| 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 (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...
TV-46046 is an investigational injectable contraceptive developed by Teva Pharmaceutical Industries Limited. It is a small molecule formulation studied for contraception in women of reproductive age. The product is also referenced as TV-46046 - 400 mg/mL and TV-46046-mL. It remains in clinical development and is not approved for marketing.
TV-46046 is being studied for contraception in women of reproductive age. Clinical trials have also listed pregnancy among the conditions evaluated. The program is designed around injectable administration of medroxyprogesterone acetate, with studies assessing pharmacokinetics, ovulation suppression, and injection tolerability in healthy female volunteers.
TV-46046 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva has sponsored the Phase 1 clinical program evaluating the injectable contraceptive candidate in healthy women of reproductive age across sites in the United States and the Dominican Republic.
TV-46046 is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. Three completed Phase 1 trials have evaluated its pharmacokinetics, ovulation suppression, and subcutaneous injection pain and local tolerability in healthy female volunteers.
TV-46046 has been studied in completed Phase 1 trials including NCT04682353, which evaluated medroxyprogesterone acetate pharmacokinetics after injection in 60 healthy women; NCT03700658, which assessed injection pain and local tolerability after subcutaneous administration in 27 women; and NCT02817464, which evaluated ovulation suppression and pharmacokinetics in 12 women with ovulatory cycles.