Sebela Women's Health Inc.
To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept
Study Design: Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 5 years Number of Subjects: Approximately 1,525 subjects will be enrolled into the study Study Population: Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk for pregnancy and who desire a long-term intrauterine contraceptive for birth control will be eligible for this study.
Inclusion Criteria: 1. Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed consent/assent and in good general health; 2. History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones or prior to recent pregnancy or spontaneous or induced abortion; 3. Sexually active with a male partner who has not had a vasectomy nor other known fertility problems; 4. Reasonably expect to have coitus at least once monthly during the study period; 5. In a mutually monogamous relationship of at least 3 months duration at time of consent; 6. S…
Levonorgestrel-Releasing Intrauterine System