Mirena Extension Trial (MET)

Bayer

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02985541

18649

Details and patient eligibility

About

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.

Enrollment

364 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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)