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Levosert-20
Levosert-20 is a levonorgestrel-releasing intrauterine system designed to provide long-acting contraception and reduce menstrual bleeding.
Levosert-20 is a levonorgestrel-releasing intrauterine system designed to provide long-acting contraception and reduce menstrual bleeding. Used for Contraception, Reduction of menorrhagia (heavy menstrual bleeding).
At a glance
| Generic name | Levosert-20 |
|---|---|
| Sponsor | Uteron Pharma S.A. |
| Drug class | Intrauterine contraceptive system (IUS) |
| Target | Progesterone receptor (local uterine effect) |
| Modality | Small molecule |
| Therapeutic area | Contraception / Gynecology |
| Phase | Phase 3 |
Mechanism of action
Levosert-20 releases levonorgestrel, a synthetic progestin, directly into the uterine cavity at a controlled rate. This local hormonal delivery thickens cervical mucus, alters the endometrium to prevent implantation, and may inhibit sperm transport, providing contraceptive efficacy while minimizing systemic hormone exposure compared to oral contraceptives.
Approved indications
- Contraception
- Reduction of menorrhagia (heavy menstrual bleeding)
Common side effects
- Irregular bleeding or spotting
- Amenorrhea
- Pelvic pain or cramping
- Device expulsion
- Headache
Key clinical trials
- Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding (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:
- Levosert-20 CI brief — competitive landscape report
- Levosert-20 updates RSS · CI watch RSS
- Uteron Pharma S.A. portfolio CI