Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
levonorgestrel/EE 0.15/0.03 and EE · 3 trials · 2 indications
Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| 1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets | DRUG | 1 tablet daily |
| levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets | DRUG | 1 tablet daily |
| levonorgestrel/EE 0.15/0.03 mg tablets and placebo | DRUG | 1 tablet daily |
| Placebo tablet | DRUG | 1 tablet daily by mouth |
Inclusion Criteria: * Participant in the earlier Phase 3 Seasonique clinical trial Exclusion Criteria: * Any contraindication to the use of oral contraceptives
Levonorgestrel/EE 0.15/0.03 and EE is an oral contraceptive combination tablet used for contraception and for the treatment of dysmenorrhea, or cyclic pelvic pain. It combines levonorgestrel with ethinyl estradiol and is being developed by Teva Pharmaceutical Industries Limited as a small molecule product in the endocrine therapeutic area.
Levonorgestrel/EE 0.15/0.03 and EE targets the progesterone receptor, or PGR, acting as an agonist. The levonorgestrel component binds and activates this receptor, while the ethinyl estradiol component contributes estrogenic activity. This receptor-level activity underlies the product's use in contraception and in managing cyclic pelvic pain.
Levonorgestrel/EE 0.15/0.03 and EE is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating the combination tablet in contraception and dysmenorrhea.
Levonorgestrel/EE 0.15/0.03 and EE is in Phase 3 development. Two completed trials are recorded for the program, one Phase 3 contraception study and one Phase 3 dysmenorrhea study, along with an earlier Phase 2 dysmenorrhea study. No trials are currently listed as active.
The program includes NCT00196352, a Phase 3 multicenter safety study of the oral contraceptive in contraception with 320 enrolled participants, and NCT00196365, a Phase 3 efficacy study in dysmenorrhea with 97 participants. An earlier Phase 2 dysmenorrhea study, NCT00196313, enrolled 95 participants. All three are completed and were conducted in the United States.
Yes. Levonorgestrel/EE 0.15/0.03 and EE is also known as Seasonique, and the clinical trials for this asset are registered under that name. Other listed names include levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets and levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets, which describe the same combination product.