Trial Profile
Multi-center, Open-label, Uncontrolled Study to Assess Contraceptive Efficacy and Safety of Mirena During Extended Use Beyond 5 Years in Women 18 to 35 Years of Age Including a Subgroup Evaluation of Treatment Effect on Heavy Menstrual Bleeding
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 18 Jan 2023
Price :
$35
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At a glance
- Drugs Levonorgestrel (Primary)
- Indications Menstruation disorders; Pregnancy
- Focus Therapeutic Use
- Acronyms MET
- Sponsors Bayer
- 09 Jan 2023 Results of a popPK model analysis performed using data from this trail published in the Contraception
- 09 Sep 2022 Results (n=362) assessing the efficacy and safety of 52-mg LNG-IUS during extended use beyond 5 and up to 8 years, published in the American Journal of Obstetrics and Gynecology.
- 18 Aug 2022 According to a Bayer media release, the eight-year data from the extension trial were published in abstract form at the American College of Obstetricians and Gynecologists (ACOG) in 2022. The full paper will be published in due course.