This is a Phase IV, prospective, multicenter, open-label, controlled, non-randomized trial in female subjects between 14 to 45 years of age who are postmenarcheal for at least two years and premenopausal. Subjects who choose to take the trial medication (LF111) will be compared to subjects who choose to use non-hormonal contraceptive methods, enrolled in a 1:1 ratio. Subjects will also be separated into two cohorts, cohort 1 as adolescents aged 14-17, and cohort 2 as adults aged 18-45.~At Visit 1 (screening), informed consent/assent will be obtained, and the screening procedures will be performed. At Visit 2 (allocation to treatment), after confirming the subject's eligibility, subjects who choose to use LF111 for pregnancy prevention will be provided LF111. The subjects will attend additional on-site visits 6 months and 12 months after Visit 2 (end of investigational phase) or within one week after premature trial discontinuation for routine safety assessments.~The primary objective of this study is to evaluate the impact of LF111 on bone mineral density (BMD) at the lumbar spine after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods. Secondary objectives include further evaluating the impact of LF111 on BMD and bone turnover after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods and assessing the general safety and tolerability of LF111 in comparison to non-hormonal contraceptive methods. Exploratory objectives include evaluating the impact of LF111 on body fat and lean mass after 12 months (13 medication cycles) of investigation.
The purpose of this study is to evaluate the impact of LF111 (drospirenone) on bone mineral density at the lumbar spine after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods.