Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–35
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
