Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DRSP/EE 20 µg · 1 trial · 1 indication
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
| Arm | Type | Description |
|---|---|---|
| DRSP 3 mg/EE 20 µg (13 cycles) | 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; treatment duration 52 weeks (13 cycles) |
| DRSP 3 mg/EE 30 µg (6 cycles) | EXPERIMENTAL | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
| Name | Type | Description |
|---|---|---|
| DRSP 3 mg/EE 20 µg (13 cycles) | DRUG | 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; treatment duration 52 weeks (13 cycles) |
| DRSP 3 mg/EE 30 µg (6 cycles) | DRUG | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) |
Inclusion Criteria: * Patients aged 20 years or older at obtaining informed consent * Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment * Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruatio...
DRSP/E2 is a combination of drospirenone and estradiol being developed for use in postmenopause, dysmenorrhea, and vasomotor symptoms such as hot flashes. It is a small molecule therapy intended for female patients, with clinical trials conducted in the United States, Japan, and other countries.
DRSP/E2 is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer is conducting clinical trials to evaluate the drug's safety and efficacy for postmenopausal symptoms and dysmenorrhea.
DRSP/E2 is in Phase 3 clinical development for postmenopause and vasomotor symptoms, based on completed Phase 3 trials. It is an investigational drug and has not been reported as FDA approved. Additional Phase 2 testing was completed for dysmenorrhea.
DRSP/E2 has completed several clinical trials, including NCT00446199, a Phase 3 study for vasomotor symptoms with 735 participants in the United States, and NCT00522873, a Phase 3 endometrial safety study for postmenopause with 662 participants across multiple countries. A Phase 2 trial, NCT00461305, studied dysmenorrhea in Japan.
DRSP/E2 combines drospirenone, a progestin, with estradiol, an estrogen. This hormone therapy is designed to relieve symptoms associated with menopause and menstrual disorders by supplementing or balancing hormone levels in the body.