LCS16 vs. COC User Satisfaction and Tolerability Study

Multi-center, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 16 μg LNG/Day Initial in Vitro Release Rate (LCS16) in Comparison to a Combined Oral Contraceptive (COC) Containing 30 μg Ethinyl Estradiol and 3 mg Drospirenone (Yarina®) in Young Nulliparous and Parous Women (18 - 29 Years) Over 12 Months of Use (With an Option for Extended Use of LCS16 for up to 5 Years)

To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.

Inclusion Criteria:

• The subject has signed and dated the Informed Consent Form (ICF).
• The subject is healthy when requesting contraception.
• The subject is between 18 - 29 years of age (inclusive) at the time of signing the ICF.
• The subject has normal or clinically insignificant cervical smear for oncocytology (i.e. Pap test) not requiring further follow up (a cervical smear has to be taken at the Screening Visit [Visit 1] or a normal result has to have been documented within the previous 6 months).
• The subject has a history of regular (i.e., endogenous cyclicity without hormonal contraceptive use) cyclic menstrual periods (length of cycle 21 - 35 days), as confirmed by the subject.
• The subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Exclusion Criteria:

• Pregnancy or current lactation (less than 6 weeks postpartum or since abortion before the Screening Visit)
• Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit.
• Chronic, daily use of drugs that may increase serum potassium levels.
• Undiagnosed abnormal genital bleeding.
• Acute cervicitis or vaginitis (until successfully treated).
• Lower urinary tract infection (until successfully treated).
• Acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections.
• Congenital or acquired uterine anomaly including fibroids, in the opinion of the investigator, which would interfere with insertion and/or retention of the intrauterine system (i.e., if they distort the uterine cavity).
• Cervical neoplasia, uterine or cervical malignancy, or sex hormone-dependent tumors.
• History of migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.