Mirena Extension Trial

• Status: Completed
• Trial end date: 2021-05-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Levonorgestrel

Criteria

Inclusion Criteria:

• Signed and dated informed consent

• Women, 18 to 35 years of age at the time of screening (visit 1) who are currently using Mirena for contraception or for contraception and heavy menstrual bleeding. The duration of use of the current Mirena has to be at least 4 years 6 months at the start of screening phase but not more than 5 years at visit 2 and the woman is willing to continue with its use and has a continuing need for contraception.

• Normal or clinically insignificant cervical smear not requiring further follow up

Exclusion Criteria:

• Menopausal symptoms with Follicle-stimulating hormone>30 mIU/ml

• Pregnancy or suspicion of pregnancy

• Uterine bleeding of unknown etiology

• Untreated acute cervicitis or vaginitis or other lower genital tract infections

• Increased susceptibility to pelvic infection

• Acute pelvic inflammatory disease (PID) or a history of PID unless successfully treated and which, in the investigator's opinion, has not negatively affected subject's fertility

• Congenital or acquired uterine anomaly if it distorts the uterine cavity

• History of, diagnosed or suspected genital or other malignancy and untreated cervical dysplasia

• Any active acute liver disease or liver tumor (benign or malignant)

• Clinically significant endometrial polyp(s)