Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
levonorgestrel/EE 0.15/0.03 and EE · 2 trials · 1 indication
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 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: * Moderate to severe menstrual-related pain * Regular spontaneous menstrual cycles Exclusion Criteria: * Any contraindication to the use of oral contraceptives * Treatment with an oral contraceptive in the last 3 months * Previous treatment failure with an extended oral contra...
Levonorgestrel/EE 0.15/0.03 and EE is an investigational small molecule being developed for the treatment of dysmenorrhea, which is severe menstrual pain. It is a combined oral contraceptive containing levonorgestrel and ethinyl estradiol. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Levonorgestrel/EE 0.15/0.03 and EE is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker symbol TEVA. The drug is in Phase 3 clinical development for the treatment of dysmenorrhea.
Levonorgestrel/EE 0.15/0.03 and EE is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of dysmenorrhea, with two completed clinical trials supporting its development.
Levonorgestrel/EE 0.15/0.03 and EE has been studied in two completed clinical trials. NCT00196313 was a Phase 2 study with 95 participants, and NCT00196365 was a Phase 3 study with 97 participants. Both trials evaluated the efficacy of the drug for treating cyclic pelvic pain associated with dysmenorrhea in the United States.
Levonorgestrel/EE 0.15/0.03 and EE is the drug being evaluated in clinical trials under the brand name Seasonique. The trials NCT00196313 and NCT00196365 both reference Seasonique in their titles. Seasonique is a combined oral contraceptive containing levonorgestrel and ethinyl estradiol, studied for dysmenorrhea.