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Mirena (BAY86-5028)
Mirena releases levonorgestrel directly into the uterus to prevent pregnancy and reduce menstrual bleeding through local hormonal suppression.
Mirena releases levonorgestrel directly into the uterus to prevent pregnancy and reduce menstrual bleeding through local hormonal suppression. Used for Contraception, Heavy menstrual bleeding (menorrhagia).
At a glance
| Generic name | Mirena (BAY86-5028) |
|---|---|
| Sponsor | Bayer |
| Drug class | Intrauterine device (IUD), progestin-releasing |
| Target | Progesterone receptor (local uterine effect) |
| Modality | Small molecule |
| Therapeutic area | Contraception, Gynecology |
| Phase | FDA-approved |
Mechanism of action
Mirena is a T-shaped intrauterine device (IUD) that continuously releases the synthetic progestin levonorgestrel into the uterine cavity. This local hormonal delivery thickens cervical mucus, inhibits sperm transport, and suppresses endometrial proliferation, resulting in contraceptive efficacy and reduced menstrual flow. The device provides long-acting reversible contraception for up to 5 years.
Approved indications
- Contraception
- Heavy menstrual bleeding (menorrhagia)
Common side effects
- Irregular bleeding or spotting
- Amenorrhea
- Pelvic pain or cramping
- Headache
- Breast tenderness
- Acne
- Device expulsion
Key clinical trials
- Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months (PHASE3)
- LCS16 vs. COC User Satisfaction and Tolerability Study (PHASE3)
- JAYDESS Drug Utilization Study in Sweden
- Mirena Extension Trial (PHASE3)
- Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
- Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
- A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components (PHASE2)
- A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years
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:
- Mirena (BAY86-5028) CI brief — competitive landscape report
- Mirena (BAY86-5028) updates RSS · CI watch RSS
- Bayer portfolio CI