NCT02985541

Mirena Extension Trial

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: Phase 3
• Study type: Interventional
• Enrollment: 364 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding \[HMB\]) and safety will be assessed.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Levonorgestrel IUS (Mirena, BAY86-5028)	Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.

Timeline

• Start date: 2016-12-22
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2016-12-07
• Last updated: 2022-04-28
• Results posted: 2022-04-28

Locations

49 sites across 1 country: United States

Regulatory

• FDA-regulated drug study