LCS16 vs. COC User Satisfaction and Tolerability Study
LCS16 vs. COC User Satisfaction and Tolerability Study
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.