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/E2 is a combination of drospirenone and estradiol being developed for dysmenorrhea, postmenopause, and vasomotor symptoms. It is a small molecule therapy studied in postmenopausal women and those with menstrual pain. The drug is currently in Phase 3 clinical development and is not yet approved.
DRSP/E2 contains drospirenone, a progestin, and estradiol, an estrogen. It works by providing hormone replacement to alleviate symptoms associated with menopause and menstrual disorders. The combination targets hormone receptors to reduce hot flashes and other vasomotor symptoms.
DRSP/E2 is developed by Bayer AG, a multinational pharmaceutical company. Bayer is conducting clinical trials to evaluate the safety and efficacy of this hormone therapy for conditions like vasomotor symptoms and dysmenorrhea.
DRSP/E2 is in Phase 3 clinical development. It has completed Phase 3 trials for vasomotor symptoms and postmenopause, as well as a Phase 2 trial for dysmenorrhea. The drug is investigational and has not received FDA approval.
DRSP/E2 has completed several trials, including NCT00446199 for vasomotor symptoms with 735 participants, NCT00461305 for dysmenorrhea with 420 participants, and NCT00522873 for endometrial safety in postmenopause with 662 participants. All trials are completed.
DRSP/E2 is a specific combination of drospirenone and estradiol. It is not the same as other hormone therapies that use different progestins or estrogens. The drug is being studied for its unique formulation and potential benefits in menopausal and menstrual conditions.