Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as YAZ (SH T00186D)
YAZ · 5 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| YAZ (SH T00186, BAY86-5300) | DRUG | 20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd |
| YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) | DRUG | Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles |
| Placebo | DRUG | The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle) |
| Yasminelle (SH T 00186 D) | DRUG | SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each |
Inclusion Criteria: * Healthy women between 18 and 45 requesting oral contraception. * Smokers may not exceed 30 years of age. Exclusion Criteria: * The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study. * Pregnan...
YAZ is an oral contraceptive used for contraception and for the treatment of moderate acne vulgaris in women. It is a small molecule combination product containing drospirenone 3 mg and ethinyl estradiol 0.02 mg. Clinical development has covered both contraceptive use and acne treatment.
YAZ is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical trials evaluating YAZ for contraception and acne vulgaris.
YAZ is in Phase 3 development. Its clinical program includes Phase 3 trials in contraception and acne vulgaris, along with a Phase 2 study of missed pills and follicular development. All listed trials are completed, and no trials are currently active.
YAZ has been studied in completed trials including NCT00819312, a Phase 3 oral contraceptive registration study in China and Hong Kong; NCT00656981 and NCT00651469, Phase 3 placebo-controlled acne trials in the United States; and NCT00673686, a Phase 2 missed-pill study in the Netherlands.