Contraception

- Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.
- Normal cervical smear (normal cervical smear within the last six months prior to visit 1 presented in writing can be accepted. The cervical smear should be analyzed and reported according to the Bethesda System.)
- Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion).
- Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

- Known or suspected pregnancy or is lactating.
- Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 2.
Note: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation.
- History of ectopic pregnancies.
Note: For Korea only: History of ectopic pregnancies or high probability of ectopic gestation.
- Infected abortion within 3 months prior to visit 1.
Note: For Korea only: Endometritis after delivery or infected abortion within 3 months prior to visit 1.
- Abnormal uterine bleeding of unknown origin.
- Any genital infection (until successfully treated).
- History of, or current, pelvic inflammatory disease
- Congenital or acquired uterine anomaly.
- Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS.
- History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.
- Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.
- Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study
- Clinically significant ovarian cyst(s)
- Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication, and if entering subset: any sex-hormone administration within one month prior to start of the study medication.