Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SH T04740B · 1 trial · 1 indication
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
| Arm | Type | Description |
|---|---|---|
| DRSP 1 mg/EE 20 μg | EXPERIMENTAL | 1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle |
| DRSP 2 mg/EE 20 μg | EXPERIMENTAL | 1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle |
| DRSP 3 mg/EE 20 μg | EXPERIMENTAL | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle |
| Placebo | PLACEBO_COMPARATOR | 1 tablet per day placebo for 28 days in each 28-day cycle |
| Name | Type | Description |
|---|---|---|
| SH T04740B | DRUG | Drospirenone 1mg/EE 20µg (ß-CDC) |
| SH T00186DF | DRUG | Drospirenone 3 mg/EE 20µg (ß-CDC) |
| SH T04740F | DRUG | Drospirenone 2 mg/EE 20µg (ß-CDC) |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Patients aged 20 years or older at obtaining informed consent * Patients having the normal menstrual cycle (28+/-3 days) in the latest two menses before the final enrollment * Patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the fi...
SH T04740B is an investigational small molecule being studied for the treatment of dysmenorrhea, which is severe pelvic pain during menstruation. It is currently in clinical development and has not been approved by regulatory authorities.
SH T04740B is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY.
SH T04740B is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug that has not yet received regulatory approval.
SH T04740B has one completed clinical trial, registered as NCT00511797. This was a Phase 2, randomized, double-blind, placebo-controlled study conducted in Japan with 249 female participants aged 20 years and older, evaluating the drug for dysmenorrhea.
SH T04740B is associated with the clinical trial NCT00511797, which is titled 'SH T00186 Phase II/III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study.' The trial investigated a drospirenone-based product, and SH T04740B may be a related compound, but the exact relationship is not specified.