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BAY86-5300 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAY86-5300 | DRUG | 0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser supported by a reminder function |
Inclusion Criteria: * Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection Exclusion Criteria: * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) * Body mass in...
BAY86-5300 is an investigational oral contraceptive being developed for contraception. It is a small molecule in the endocrine therapeutic area. As of the available data, it is in Phase 3 clinical development and has not been approved by regulatory authorities.
BAY86-5300 is being developed by Bayer AG, which trades under the ticker BAYRY. The company is conducting clinical trials to evaluate the drug as an oral contraceptive.
BAY86-5300 is in Phase 3 clinical development. One Phase 3 trial has been completed, with 508 participants enrolled. The drug remains investigational and is not yet approved for any use.
BAY86-5300 has one completed Phase 3 trial, NCT01257984, which studied compliance with the oral contraceptive SH T00186D in a flexible extended regimen supported by a dispenser with a reminder function. The trial enrolled 508 healthy female participants aged 18 years and older in France, Germany, Italy, Spain, and the United Kingdom.
Yes, BAY86-5300 is also known as SH T00186D. The Phase 3 clinical trial NCT01257984 refers to the drug as SH T00186D, indicating that these names refer to the same investigational oral contraceptive.