A pivotal, multicentre, randomised, open-label, parallel-group trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 9 cycles in comparison with Desogestrel tablets 0.075 mg.

Prevention of pregnancy

Overall Pearl Index (PI) in non-breastfeeding women aged ≤ 35 years (at the time of trial enrolment).

[Secondary efficacy:] Overall PI in women aged ≤ 35 years and in women > 35 years (at the time of trial enrolment)., [Secondary efficacy:] PI after correction for back-up contraception and sexual activity (evaluable cycles)., [Secondary efficacy:] PI after correction for back-up contraception and sexual activity (evaluable cycles) in women aged ≤ 35 years and in women > 35 years (at the time of trial enrolment)., [Secondary efficacy:] PI for method failure., [Secondary efficacy:] PI for method failure in women aged ≤ 35 years and in women > 35 years (at the time of trial enrolment)., [Secondary efficacy:] Pregnancy ratio by life table analysis., [Secondary efficacy:] Pregnancy ratio by life table analysis in women aged ≤ 35 years and in women > 35 years (at the time of trial enrolment)., [Secondary safety and tolerability:] Adverse events (AEs)., [Secondary safety and tolerability:] Vital Signs., [Secondary safety and tolerability:] Physical examination., [Secondary safety and tolerability:] Gynaecological examination, incl. transvaginal ultrasound examination and cervical cytology., [Secondary safety and tolerability:] Mastodynia/mastalgia/dysmenorrhea., [Secondary safety and tolerability:] Proportion of subjects with bleeding during Cycles 2-9 (non-inferiority test, key secondary endpoint)., [Secondary safety and tolerability:] Proportion of subjects with bleeding / spotting in each cycle., [Secondary safety and tolerability:] Proportion of subjects with absence of bleeding., [Secondary safety and tolerability:] Proportion of subjects with prolonged bleeding., [Secondary safety and tolerability:] Number of days per cycle and reference period with bleeding and with spotting., [Secondary safety and tolerability:] Number of bleeding / spotting episodes per reference period., [Secondary safety and tolerability:] Duration of bleeding / spotting episodes by cycle and reference period., [Secondary safety and tolerability:] Clinical laboratory parameters (haematology, biochemistry including estradiol levels, TSH and urinalysis; in a subset of subjects: haemostatic variables, carbohydrate metabolism, bone mineral density biomarkers, SHBG)., [Secondary safety and tolerability:] IP acceptability., [Secondary safety and tolerability:] Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF).

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