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Label indication OCELLA® is indicated for use by females of reproductive potential to prevent pregnancy. OCELLA is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) FDA label
Also known as Yasmin
Yasmin 20 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Yasmin 20 | DRUG | Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral) |
| Mercilon | DRUG | Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral) |
| Yasmin | DRUG | 30 µg ethinylestradiol, 3mg drospirenone |
| Marvelon | DRUG | 30 µg ethinylestradiol, 150 µg desogestrel |
Inclusion Criteria: * Healthy female volunteer aged 18-35, * Smokers 18-30 Exclusion Criteria: * Contraindications for using hormonal contraceptives
Yasmin 20 is an oral contraceptive used for contraception in women. It is a small molecule combination product developed by Bayer AG. Its clinical program in this indication includes two completed Phase 3 trials that together enrolled 1,295 healthy female volunteers.
Yasmin 20 is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor behind the clinical program for the product, including the Phase 3 studies conducted in Europe and China.
Yasmin 20 has been studied in Phase 3 clinical development for contraception. Both of its Phase 3 trials are completed, and no trials are currently active. The program enrolled a total of 1,295 participants across the two studies.
Yasmin 20 has been evaluated in two completed Phase 3 trials. NCT00624130 compared Yasmin 20 with Mercilon in 453 healthy female volunteers in Austria, Estonia, Finland, and Lithuania. NCT00185419 compared Yasmin with Marvelon in 842 Chinese women requiring contraception.
Yasmin 20 is also known as Yasmin, and related names include Yasmin (EE30/DRSP, BAY86-5131) and Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131). These names refer to the same Bayer contraceptive product and its ethinyl estradiol and drospirenone composition.
Both Yasmin 20 Phase 3 trials were randomized and active controlled, comparing the product against other oral contraceptives rather than placebo. They enrolled healthy female volunteers, with minimum ages of 18 years in NCT00624130 and 20 years in NCT00185419. Neither study used a double-blind design.