Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DRSP (ZK 30595) dose 1 (SH T04984F)
DRSP dose 1 · 3 trials · 4 indications
The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as \[(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)\] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as \[(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)\] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
| Arm | Type | Description |
|---|---|---|
| 0.25mg DRSP / 0.5mg E2 (BAY86-4891) | EXPERIMENTAL | One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle). |
| 0.5mg NETA / 1.0mg E2 (Activella) | ACTIVE_COMPARATOR | One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle). |
| 0.5mg DRSP / 0.5mg E2 (BAY86-4891) | EXPERIMENTAL | One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). |
| Estradiol (E2 0.3mg) | EXPERIMENTAL | One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle). |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle). |
| 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 |
|---|---|---|
| 0.25mg DRSP / 0.5mg E2 (BAY86-4891) | DRUG | One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle). |
| 0.5mg NETA / 1.0mg E2 (Activella) | DRUG | One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle). |
| 0.5mg DRSP / 0.5mg E2 (BAY86-4891) | DRUG | One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). |
| Estradiol (E2 0.3mg) | DRUG | One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle). |
| Placebo | DRUG | Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle). |
| 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: * Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment) * Non-hysterectomized women. Exclusion Criteria: * Usual exclusion criteria for hormone therapy apply.
DRSP dose 1 is an investigational small molecule developed by Bayer AG (ticker BAYRY). It is being studied in women for dysmenorrhea, postmenopause, and vasomotor symptoms. The program is in Phase 2 development, and the trials listed for this asset have been completed.
DRSP dose 1 is being studied for dysmenorrhea, postmenopause, and vasomotor symptoms, which include hot flashes. Clinical trials have enrolled women aged 20 years and older, with most studies requiring participants to be at least 40 years old. It remains investigational and is not described as approved.
Bayer AG develops DRSP dose 1. Bayer trades on the OTC market under the ticker BAYRY. The company is the sponsor behind the clinical program evaluating this asset across dysmenorrhea, postmenopause, and vasomotor symptoms.
DRSP dose 1 is in Phase 2 development. The program includes completed Phase 2 and Phase 3 studies, and no trials are currently active. Because the asset is still in clinical development, it is investigational rather than approved.
DRSP dose 1 has been evaluated in completed studies including NCT00522873, an endometrial safety study in postmenopause; NCT00461305, a safety study of ethinylestradiol and drospirenone in dysmenorrhea in Japan; and NCT00446199, a low-dose hormone therapy study for vasomotor symptoms and hot flashes.