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:

• Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
• Women who either

• have never used hormonal contraceptives before consent/assent (naïve users), or
• 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
• directly switch from another hormonal contraceptive (switchers).
• 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.

Exclusion criteria

• Pregnancy or wish of pregnancy.
• Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
• History of infertility.
• Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
• Unexplained amenorrhoea.
• Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.