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BAY86-4891 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAY86-4891 (Estradiol / Drospirenone) | DRUG | Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles |
Inclusion Criteria: * Healthy female volunteers, * Age 18 - 35 years Exclusion Criteria: * Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease) * Regular intake of medication * Clinically relevant findings (ECG, bloo...
BAY86-4891 is an investigational oral contraceptive being developed by Bayer AG. It is a small molecule combination product containing estradiol and drospirenone, studied for the prevention of pregnancy in healthy young females. It has been evaluated in a Phase 2 clinical trial and is not approved for marketing.
BAY86-4891 is being studied for contraception in healthy young females. The Phase 2 trial evaluated inhibition of ovulation across three treatment cycles in women aged 18 years and older. The drug is investigational and has not been approved for contraceptive use.
Bayer AG develops BAY86-4891. Bayer trades on the OTC market under the ticker BAYRY. The company sponsored the Phase 2 contraception study conducted in Germany.
BAY86-4891 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for any indication.
BAY86-4891 has been studied in one completed Phase 2 trial, NCT00631124, titled a study to evaluate inhibition of ovulation of two oral estrogen/progestogen regimens in healthy young females over three treatment cycles. The randomized, double-blind, controlled trial enrolled 103 participants in Germany.