FDA extends use of intrauterine contraceptive device Mirena up to 6 years

The Extension Trial study was 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 of heavy menstrual bleeding [HMB]) and safety were also assessed.

The study design consisted of 362 women aged 18 to 35 years who had been using Mirena for not less than 4.5 years and no more than 5 years at enrollment. The primary endpoint was the pregnancy rate calculated as the Pearl Index (PI) at the end of year 6. Women, 18 to 35 years of age at the time of screening (visit 1) who are currently using Mirena for contraception or contraception and heavy menstrual bleeding. the women were willing to continue with its use and have a continuing need for contraception.

On data analysis, researchers have revealed that the PI for the 6th year of use was 0.35 with a 95% upper confidence limit of 1.95 based on the 1 pregnancy that occurred during year 6 and within 7 days after Mirena removal or expulsion.

As the Mirena Extension Trial is still ongoing, no further details have been updated till now.

Primary source: mirena-us.com.

For details click on the link: Mirena [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals; 2020.