Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DRSP/ E2 · 2 trials · 3 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.
| 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). |
| 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). |
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 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.