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EV/DNG (Qlaira, BAY86-5027)
EV/DNG is an estradiol valerate and dienogest combination oral contraceptive that prevents ovulation through hormonal suppression.
EV/DNG is an estradiol valerate and dienogest combination oral contraceptive that prevents ovulation through hormonal suppression. Used for Contraception in women of reproductive age, Treatment of heavy menstrual bleeding in women desiring contraception.
At a glance
| Generic name | EV/DNG (Qlaira, BAY86-5027) |
|---|---|
| Sponsor | Bayer |
| Drug class | Oral contraceptive (combined estrogen-progestin) |
| Target | Estrogen receptor, progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception / Women's Health |
| Phase | Phase 3 |
Mechanism of action
Estradiol valerate is a natural estrogen that is metabolized to estradiol, while dienogest is a progestin with antimineralocorticoid activity. Together, they suppress the luteinizing hormone (LH) surge and follicle-stimulating hormone (FSH), preventing ovulation and thickening cervical mucus to provide contraceptive efficacy. The combination is designed to provide consistent hormone levels with a more physiologic estrogen profile.
Approved indications
- Contraception in women of reproductive age
- Treatment of heavy menstrual bleeding in women desiring contraception
Common side effects
- Headache
- Nausea
- Breast tenderness
- Irregular bleeding/spotting
- Mood changes
Key clinical trials
- To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada) (PHASE3)
- Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy
- Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea
- Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache (PHASE3)
- Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
- Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding (PHASE3)
- Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding (PHASE3)
- Effects of SH T00658ID on Libido (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:
- EV/DNG (Qlaira, BAY86-5027) CI brief — competitive landscape report
- EV/DNG (Qlaira, BAY86-5027) updates RSS · CI watch RSS
- Bayer portfolio CI