Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Valette · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Arm 3 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Valette | DRUG | 1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles |
| Diane | DRUG | 1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles |
| Placebo | DRUG | 2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles |
| Valette (Dienogest/EE30, BAY86-5038) | DRUG | Oral contraceptive extended cycles |
Inclusion Criteria: * Patients with mild to moderate facial papulopustular acne Exclusion Criteria: * Contraindication against use of hormonal contraceptives
Valette is a small molecule oral contraceptive in Phase 3 clinical development. It is also being studied for the treatment of acne vulgaris. The drug is being developed by Bayer AG.
Valette is being developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is currently in Phase 3 clinical development for use as an oral contraceptive and for treating acne vulgaris.
Valette is in Phase 3 clinical development. It is an investigational drug being studied for use as an oral contraceptive and for the treatment of acne vulgaris. It is not yet approved by regulatory authorities.
Valette has been studied in two completed Phase 3 clinical trials. One trial, NCT00280657, evaluated the safety and efficacy of Valette in treating acne papulopustulosa in 1326 female participants aged 16 years and older. Another trial, NCT00302666, was a bleeding pattern study in 1315 healthy female participants aged 18 years and older.
Valette is the drug name used in clinical trials for this oral contraceptive and acne treatment. No alternative names are listed for Valette in the clinical trial records.