Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY86-5016, SH P00331F · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BAY86-5016, SH P00331F | DRUG | Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD) |
| SH P00331N | DRUG | Drug amount per patch: 0.6 mg EE2 + 6 mg NGM |
Inclusion Criteria: * Healthy female volunteer aged 18-35, smokers 18-30 Exclusion Criteria: * Contraindications for using hormonal contraceptives
BAY86-5016 is an investigational small molecule being developed for contraception. It is currently in Phase 3 clinical development, though the specific trial has been completed. The drug is being studied in healthy female volunteers aged 18 years and older.
BAY86-5016 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The drug is also known by the alternative name SH P00331F.
BAY86-5016 is in Phase 3 clinical development. The Phase 3 trial, NCT00185354, has been completed. As an investigational drug, it has not yet been approved by regulatory authorities and remains in clinical development.
BAY86-5016 has one completed Phase 3 clinical trial, NCT00185354, titled 'FC Patch Comparator Study'. This randomized, active-controlled trial enrolled 422 healthy female participants across Austria, Finland, France, and Spain to evaluate the drug for contraception.
Yes, BAY86-5016 is also known as SH P00331F. Both names refer to the same investigational drug being developed by Bayer AG for contraception. The drug is currently in Phase 3 clinical development.