A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception

Exclusion Criteria

• •1. Planning pregnancy during study participation through the End -of -Treatment Visit (Visit 11, Day 240).
• •2. Is post-partum and has not had 2 spontaneous menses (1 cycle) since delivery or 1 menses since first or second trimester abortion or miscarriage.
• •3. Breastfeeding or within 30 days of discontinuing breastfeeding unless the participant has already had 2 menses (1 cycle) following discontinuation of breastfeeding.
• •4. Undiagnosed abnormal genital bleeding.
• •5. Undiagnosed vaginal discharge, lesions, or abnormalities.
• •6. Participating in another clinical study involving an IP or device within 30 days prior to the Screening Visit or planning to participate in another clinical study during this study.
• •7. Not living in the catchment area of the study site.
• •8. Known hypersensitivity or contraindication to progestins, including the active substance LB or any excipients of the study treatment.
• •9. Current need for therapeutic anticoagulation or known history of thrombophilia.
• •10. Use or planned use of exogenous reproductive hormones during study participation.
• •11. Body weight change exceeding 10% over the previous year or planned significant weight loss during the study related to bariatric surgery, dieting, or planned treatment.
• •12. Uncontrolled hypertension, in which diastolic blood pressure remains ≥95 mmHg or systolic blood pressure remains ≥145 mmHg.
• •13. Smoking nicotine (e.g., cigarettes or electronic cigarettes) AND has at least 1 of the following comorbidities or conditions (at the discretion of the investigator):
• •* Current or history of venous thrombophlebitis or thromboembolic disorders (including deep vein thrombosis and pulmonary embolism).
• •* Current or history of cerebrovascular or coronary-artery disease.
• •* Valvular heart disease with thrombogenic complications.
• •* Diabetes with vascular involvement.
• •* Known inherited or acquired predisposition to venous thromboembolism or arterial thromboembolism (e.g., factor VLeiden, prothrombin mutation, antiphospholipid antibodies) or bruising within the last 12 months prior to consent.
• •14. Current or past cerebrovascular or cardiovascular disease or at risk of clotting disorders.
• •15. Impaired mobility (e.g., is wheelchair bound or bedridden) that, in the investigator's opinion, places the participant at increased risk of thrombosis.
• •16. Known or suspected carcinoma of the breast or suspected progestin-dependent neoplasia.
• •17. Known or suspected pelvic organ carcinoma.
• •18. Known Papanicolaou (Pap) or human papillomavirus (HPV) test abnormality that would require a repeat evaluation or treatment during study participation based on standard of care guidelines (American Society for Colposcopy and Cervical Pathology or American College of Obstetricians and Gynecologists).
• •19. Known benign or malignant liver tumors, renal disease, or active liver disease.
• •20. Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer) unless in remission for \>5 years.
• •21. Current or past medically diagnosed severe depression, which, in the investigator's opinion, could be exacerbated by use of a hormonal contraceptive, unless participant is on stable antidepressant medication.
• •22. Known or suspected current alcohol dependence syndrome or any recreational drug use that may affect metabolism of the IP or study compliance.
• •23. Abnormal screening laboratory values defined as:
• •1. Fasting clinical chemistry values or CBC values designated clinically significant by the investigator.
• •2. Liver function test results \>twice the upper limit of normal.
• •24. Uncontrolled thyroid disorder.