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 an oral contraceptive being developed for contraception and for the treatment of acne vulgaris, specifically acne papulopustulosa. It is a small molecule combination product studied in women, with clinical development focused on both oral contraceptive use and acne treatment.
Valette is a small molecule combination of dienogest and ethinyl estradiol 30 mcg. Its target class is hormonal, combining a progestin and an estrogen. This hormonal mechanism supports both contraceptive efficacy and reduction of acne lesions in women.
Valette is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor responsible for the clinical development program of this oral contraceptive and acne treatment candidate.
Valette is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. Two Phase 3 trials have been completed, and no active trials are currently listed for this asset.
Valette has been studied in two completed Phase 3 trials. NCT00302666 was a bleeding pattern study in Germany with 1,315 healthy female volunteers. NCT00280657 evaluated safety and efficacy in treating acne papulopustulosa across Czechia, Poland, Russia, Slovakia, and Ukraine, enrolling 1,326 women.