Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EE20/DRSP/L-5-MTHF · 2 trials · 3 indications
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 | - |
| 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 | Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone |
| EE20/DRSP (YAZ, BAY86-5300) | DRUG | Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle) |
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 an investigational oral contraceptive being developed for contraception and for treating premenstrual dysphoric disorder (PMDD), acne vulgaris, dysmenorrhea, and endometriosis. It is a small molecule combination product studied in Phase 3 clinical trials.
EE20/DRSP is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer is conducting Phase 3 clinical trials to evaluate the drug for contraceptive and other gynecologic indications.
EE20/DRSP is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Multiple Phase 3 trials have been completed, studying its efficacy and safety for contraception and related conditions.
EE20/DRSP has completed four Phase 3 trials. NCT00567164 compared flexible extended regimens to a conventional regimen in 1887 women for contraception. NCT01076582 studied hormone withdrawal symptoms in 592 women. NCT01892904 evaluated dysmenorrhea in 216 women in Japan, and NCT01902264 assessed contraception in 34 Mexican women.
EE20/DRSP is a combination of ethinyl estradiol 20 mcg and drospirenone, and it is being studied in comparison with YAZ, which contains the same hormones. The drug is also known by the code BAY86-5300 in clinical trial records.
EE20/DRSP combines ethinyl estradiol and drospirenone, a progestin. Drospirenone has anti-mineralocorticoid and anti-androgenic activity, which may contribute to its effects on hormone-related conditions. The drug works by suppressing ovulation and altering the uterine lining to prevent pregnancy.