Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
E2/DRSP dose 1 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for 24 days and DRSP (ZK 30595) dose 1 (SHT04984F) for one day and placebo for three days in a 28 day cycle |
| Arm 2 | EXPERIMENTAL | E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for 24 days and DRSP (ZK 30595) dose 1 (SHT04984F) for two days and placebo for two days in a 28 day cycle |
| Arm 3 | EXPERIMENTAL | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for days 9-16, E2/DRSP (BAY 86-4891) dose 3 (80458755) for days 17-24, and placebo for days 25-28 in a 28 day cycle |
| Arm 4 | EXPERIMENTAL | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for days 9-16, E2/DRSP (BAY 86-4891) dose 3 (80458755) for days 17-24, placebo for 3 days, and DRSP (ZK 30595) dose 1 (SHT04984F) for one day in a 28 day cycle |
| Arm 5 | EXPERIMENTAL | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 4 (80458720) for days 9-16, E2/DRSP (BAY 86-4891) dose 5 (80458712) for days 17-24, and placebo for 4 days in a 28 day cycle |
| Arm 6 | EXPERIMENTAL | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 4 (80458720) for days 9-16, E2/DRSP (BAY 86-4891)dose 5 (80458712) for days 17-24, placebo for 3 days, and DRSP (ZK 30595) dose 2 (80458690) for one day in a 28 day cycle |
| Name | Type | Description |
|---|---|---|
| E2/DRSP (BAY 86-4891) dose 1 (SH T04984E) | DRUG | Single dose administration of E2 + DRSP as a tablet |
| E2/DRSP (BAY 86-4891) dose 2 (80458739) | DRUG | Single dose administration of E2 + DRSP as a tablet |
| E2/DRSP (BAY 86-4891) dose 3 (80458755) | DRUG | Single dose administration of E2 + DRSP as a tablet |
| E2/DRSP (BAY 86-4891) dose 4 (80458720) | DRUG | Single dose administration of E2 + DRSP as a tablet |
| E2/DRSP (BAY 86-4891) dose 5 (80458712) | DRUG | Single dose administration of E2 + DRSP as a tablet |
| DRSP (ZK 30595) dose 1 (SH T04984F) | DRUG | Single dose administration of DRSP as a tablet |
| DRSP (ZK 30595) dose 2 (80458690) | DRUG | Single dose administration of DRSP as a tablet |
| Placebo | DRUG | Placebo administration in each arm |
Inclusion Criteria: * Healthy female volunteers * Age: 18 - 35 years (inclusive), smokers must not be older than 30 years at inclusion * History of regular cyclic menstrual periods (with a cycle length between 25 and 35 days) * Willingness to use barrier methods of contraception (condoms with sperm...
E2/DRSP dose 1 is an investigational oral hormonal contraceptive being developed by Bayer AG. It combines estradiol (E2) with drospirenone (DRSP) and is designed for oral contraception. It is a small molecule product candidate and remains in clinical development rather than being an approved medicine.
E2/DRSP dose 1 is being studied for oral hormonal contraception. The Phase 2 trial evaluated cycle control and safety in this indication. It is an investigational contraceptive and is not described as approved for any use.
E2/DRSP dose 1 is being developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer sponsored the clinical program for this oral hormonal contraceptive candidate.
E2/DRSP dose 1 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. It is an investigational product and is not described as FDA approved.
E2/DRSP dose 1 has been studied in one completed Phase 2 trial, NCT00653614, titled Cycle Control and Safety of E2-DRSP. The trial enrolled 635 female participants aged 18 years and older in Germany and used a randomized, double-blind, controlled design.
Yes. E2/DRSP dose 1 is also known as E2/DRSP (BAY 86-4891) dose 1 (SH T04984E). These names refer to the same Bayer oral hormonal contraceptive candidate, so searches using BAY 86-4891 or SH T04984E point to the same investigational asset.