A Trial of Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles

Inclusion Criteria

• •At Visit 1a, subjects must meet ALL of the following criteria:
• •1. Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
• •2. Women who either
• •1. have never used hormonal contraceptives before consent/assent (naïve users), or
• •2. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users) or
• •3. directly switch from another hormonal contraceptive (switchers).
• •3. Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent/assent:
• •Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months.