Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EE20/DRSP · 4 trials · 4 indications
Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary.
The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)
| Arm | Type | Description |
|---|---|---|
| EE20/DRSP(BAY86-5300)-flexibel extended regimen | EXPERIMENTAL | One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day with flexible extended regimen (24-day to 120-day active tablet intake followed by 4-day tablet free interval) |
| EE20/DRSP(BAY86-5300)-28 days cyclic regimen | ACTIVE_COMPARATOR | One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day with 28-day cyclic regimen (24-day active tablet intake followed by 4-day placebo tablet intake) |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| EE20/DRSP(BAY86-5300) | DRUG | One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day |
| Placebo | DRUG | One tablet (no active ingredient) / day and one tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day, for the first 24 weeks and the later 28 weeks, respectively |
| Dienogest | DRUG | Dienogest 1mg twice a day (bid) |
| EE20/DRSP (YAZ, BAY86-5300) | DRUG | 4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days |
| Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon) | DRUG | 4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days |
| EE20/DRSP(YAZ, BAY86-5300) | DRUG | 20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd |
Inclusion Criteria: - Dysmenorrhea patients with a total dysmenorrhea score (sum of the two sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of the last two menstruations before randomization (baseline observation phase) * Patients with dysmenorrheic pain dur...
EE20/DRSP is an investigational oral contraceptive being developed for contraception and for treating premenstrual dysphoric disorder (PMDD), acne vulgaris, dysmenorrhea, and endometriosis. It is a small molecule combination product studied in Phase 3 clinical trials.
EE20/DRSP is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer is conducting Phase 3 clinical trials to evaluate the drug for contraceptive and other gynecologic indications.
EE20/DRSP is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Multiple Phase 3 trials have been completed, studying its efficacy and safety for contraception and related conditions.
EE20/DRSP has completed four Phase 3 trials. NCT00567164 compared flexible extended regimens to a conventional regimen in 1887 women for contraception. NCT01076582 studied hormone withdrawal symptoms in 592 women. NCT01892904 evaluated dysmenorrhea in 216 women in Japan, and NCT01902264 assessed contraception in 34 Mexican women.
EE20/DRSP is a combination of ethinyl estradiol 20 mcg and drospirenone, and it is being studied in comparison with YAZ, which contains the same hormones. The drug is also known by the code BAY86-5300 in clinical trial records.
EE20/DRSP combines ethinyl estradiol and drospirenone, a progestin. Drospirenone has anti-mineralocorticoid and anti-androgenic activity, which may contribute to its effects on hormone-related conditions. The drug works by suppressing ovulation and altering the uterine lining to prevent pregnancy.