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 is intended for use as a contraceptive in women. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
E2/DRSP dose 1 is a small molecule combination of estradiol (E2) and drospirenone (DRSP). It works by combining an estrogen and a progestin to prevent ovulation and alter the uterine lining, providing contraceptive effects. The specific molecular targets are the estrogen and progesterone receptors.
E2/DRSP dose 1 is developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical trials to evaluate the safety and efficacy of this oral contraceptive.
E2/DRSP dose 1 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for its contraceptive effects and safety profile in women.
E2/DRSP dose 1 is being evaluated in a Phase 2 clinical trial with the identifier NCT00653614, titled 'Cycle Control and Safety of E2-DRSP'. This completed trial enrolled 635 women in Germany and was randomized, double-blind, and controlled.
Yes, E2/DRSP dose 1 is also known as E2-DRSP. The clinical trial NCT00653614 refers to the drug as E2-DRSP, which is a combination of estradiol and drospirenone. This naming is used interchangeably in the context of the ongoing research.