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LNG-IUS
LNG-IUS is a levonorgestrel-releasing intrauterine system that provides long-acting reversible contraception by releasing a synthetic progestin directly into the uterus.
LNG-IUS is a levonorgestrel-releasing intrauterine system that provides long-acting reversible contraception by releasing a synthetic progestin directly into the uterus. Used for Contraception, Heavy menstrual bleeding (off-label/secondary indication).
At a glance
| Generic name | LNG-IUS |
|---|---|
| Also known as | Mirena |
| Sponsor | University of Texas Southwestern Medical Center |
| Drug class | Intrauterine contraceptive device (hormonal) |
| Target | Progesterone receptor (via levonorgestrel) |
| Modality | Small molecule |
| Therapeutic area | Contraception / Reproductive Health |
| Phase | FDA-approved |
Mechanism of action
The device releases levonorgestrel (a synthetic progestin) in small amounts over several years, which thickens cervical mucus to prevent sperm penetration, alters the endometrium to prevent implantation, and may suppress ovulation in some cycles. This localized hormonal delivery provides contraceptive efficacy comparable to sterilization while maintaining reversibility.
Approved indications
- Contraception
- Heavy menstrual bleeding (off-label/secondary indication)
Common side effects
- Irregular bleeding or amenorrhea
- Abdominal/pelvic pain
- Headache
- Breast tenderness
- Device expulsion
- Perforation (rare)
Key clinical trials
- Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia (PHASE2, PHASE3)
- Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer
- Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for Niche-Related Abnormal Uterine Bleeding (NA)
- Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer (PHASE2)
- The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies (PHASE1)
- Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer (PHASE2)
- Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia (PHASE2, PHASE3)
- Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period (NA)
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:
- LNG-IUS CI brief — competitive landscape report
- LNG-IUS updates RSS · CI watch RSS
- University of Texas Southwestern Medical Center portfolio CI