Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women

Inclusion Criteria:

- Healthy female subject requesting contraception and willing to use the IVR

- Normal or clinically insignificant cervical smear not requiring further follow up (a
cervical smear has to be taken at screening visit or a normal result has to be
documented within the previous 6 months)

- History of regular cyclic menstrual periods

- Subject is willing and able to attend the scheduled study visits and comply with
study procedures

Exclusion Criteria:

- Pregnancy or lactation (less than three months since delivery, abortion, or lactation
before start of treatment)

- Any diseases or conditions that can compromise the function of the body systems and
could result in altered absorption, excessive accumulation, impaired metabolism, or
altered excretion of the study drug

- Any diseases or conditions that might interfere with the conduct of the study or the
interpretation of the results

- Any disease or condition that may worsen under hormonal treatment according to the
assessment and opinion of the investigator

- Undiagnosed abnormal genital bleeding

- Wish for pregnancy during the study

- Major surgery scheduled during the study period