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EE20/DRSP (YAZ, BAY86-5300)
EE20/DRSP is an oral contraceptive combining ethinyl estradiol and drospirenone to prevent ovulation and thicken cervical mucus.
EE20/DRSP is an oral contraceptive combining ethinyl estradiol and drospirenone to prevent ovulation and thicken cervical mucus. Used for Contraception, Acne vulgaris (moderate), Premenstrual dysphoric disorder (PMDD).
At a glance
| Generic name | EE20/DRSP (YAZ, BAY86-5300) |
|---|---|
| Also known as | SH T00186D |
| Sponsor | Bayer |
| Drug class | Oral contraceptive (combined estrogen-progestin) |
| Target | Estrogen receptor, progesterone receptor, mineralocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception / Gynecology |
| Phase | FDA-approved |
Mechanism of action
Ethinyl estradiol (EE) is a synthetic estrogen that suppresses the luteinizing hormone (LH) surge needed for ovulation. Drospirenone (DRSP) is a progestin with antimineralocorticoid activity that further inhibits ovulation and alters the endometrium and cervical mucus to prevent sperm penetration. The combination provides contraceptive efficacy through multiple mechanisms.
Approved indications
- Contraception
- Acne vulgaris (moderate)
- Premenstrual dysphoric disorder (PMDD)
Common side effects
- Nausea
- Headache
- Breast tenderness
- Breakthrough bleeding
- Mood changes
- Venous thromboembolism
Key clinical trials
- YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China (PHASE4)
- YAZ Post-marketing Surveillance in Japan
- Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis (PHASE3)
- To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea (PHASE3)
- Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea (PHASE3)
- GA YAZ ACNE in China Phase III (PHASE3)
- Regulatory Post Marketing Surveillance Study on YAZ
- Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- EE20/DRSP (YAZ, BAY86-5300) CI brief — competitive landscape report
- EE20/DRSP (YAZ, BAY86-5300) updates RSS · CI watch RSS
- Bayer portfolio CI