Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EE20/DRSP · 7 trials · 8 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)
Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)\*100, so that improvement is indicated by a larger percent change.
Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)\*100, so that improvement is indicated by a larger percent change.
The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.
| Arm | Type | Description |
|---|---|---|
| EE20/DRSP/L-5-MTHF | EXPERIMENTAL | - |
| 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 | - |
| EE20/Drospirenone (YAZ, BAY86-5300) | EXPERIMENTAL | In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol). |
| Placebo | PLACEBO_COMPARATOR | The participants of the placebo group received inert but identical-appearing, color-matched tablets. |
| Flexible (extended) regimen no. 1 of EE20/DRSP (BAY86-5300) | EXPERIMENTAL | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment |
| Flexible (extended) regimen no. 2 of EE20/DRSP (BAY86-5300) | EXPERIMENTAL | Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. |
| Conventional regimen of EE20/DRSP (YAZ, BAY86-5300) | ACTIVE_COMPARATOR | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of tablets without active substance (together resulting in one cycle of 24+4 standard treatment). 13 withdrawal bleeding episodes during one year of treatment were expected. |
| Name | Type | Description |
|---|---|---|
| EE20/DRSP/L-5-MTHF (Beyaz, BAY98-7071) | DRUG | One tablet DRSP 3 mg/EE 0.02 mg/ Levomefolate calcium 0.451 mg daily for 24 days, followed by one hormone-free tablet L-5-MTHF 0.451 mg daily for 4 days over 24 weeks |
| 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 |
| EE20/Drospirenone (YAZ, BAY86-5300) | DRUG | 20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd |
| EE20/DRSP (BAY86-5300) | DRUG | Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone |
Inclusion Criteria: * Healthy, Mexican female subjects requesting contraception * Age \>/=18 to \</=45 years (inclusive); smokers must not be older than 30 years at the time of informed consent * Normal or clinically insignificant cervical smear not requiring further follow-up; a cervical smear has...
EE20/DRSP is a small molecule combination product developed by Bayer AG that pairs ethinyl estradiol 20 mcg with drospirenone. It is being studied across women's health indications including contraception, oral contraceptive use, acne vulgaris, dysmenorrhea, endometriosis, and premenstrual dysphoric disorder. It is in Phase 3 development.
EE20/DRSP is studied for contraception and oral contraceptive use, acne vulgaris, dysmenorrhea, endometriosis, and premenstrual dysphoric disorder. Phase 3 trials have enrolled women in these indications, including studies in contraception, dysmenorrhea, endometriosis, and hormone withdrawal associated symptoms.
EE20/DRSP is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor behind the Phase 3 clinical program for this ethinyl estradiol and drospirenone combination.
EE20/DRSP is in Phase 3 development. It is investigational and has not been approved by the FDA. Two Phase 3 trials are listed as completed, and no active trials are currently recorded for this asset.
Completed Phase 3 trials include NCT01902264 in contraception in Mexico, NCT01892904 in dysmenorrhea in Japan, NCT01697111 in endometriosis in Japan, and NCT01076582 in hormone withdrawal associated symptoms across multiple countries. Total enrollment across the program is 1,921 participants.
EE20/DRSP is also known as EE20/Drospirenone, YAZ, BAY86-5300, and EE20/DRSP/L-5-MTHF, which includes Beyaz and BAY98-7071. These names refer to the same ethinyl estradiol and drospirenone development program from Bayer.