Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females

This is a Phase 3, prospective, multi-center, open-label, non-comparative study in female subjects 13 to 45 years of age (inclusive) to determine the efficacy, safety, and tolerability of LPRI-CF113 administered orally for 13 (28-day) medication cycles (Part A). Healthy, sexually active female subjects of childbearing potential, who present to the clinic seeking contraception, will be enrolled in the study.

Part B will be an investigation of bone mineral density (BMD) at the lumbar spine and BMD and bone turnover at the femoral neck, total hip, and total body. Part B will consist of a subgroup of subjects enrolled in Part A (i.e., subjects that meet all of Part A inclusion criteria and none of Part A AND Part B exclusion criteria) who are 18 to 45 years of age (inclusive at the time of screening). BMD will be assessed by dual-energy X-ray absorptiometry (DXA) scan.

The study duration (Parts A and B) for each subject will be up to approximately 404 days (28 days \[screening\] + 376 days \[Treatment and Follow-up Period\]), unless the subject meets criteria for the extended Part B Follow-up, in which the duration will be approximately 769 days (28 days \[screening\] + 376 days \[Treatment and Follow-up Period\] + 365 days \[extended Part B Follow up\]).