Casea S Contraceptive Implants (Casea S) Trial

Inclusion Criteria:

Participants may be included in the study if they meet all of the following criteria:

• willing and able to provide signed informed consent

• female between 18 to 45 years of age (inclusive)

• healthy based on results of medical evaluation including medical history, vitalsigns, and physical exam

• has regular menstrual cycle (21 to 35 days)

• not at risk for pregnancy (i.e., sterilized)

• has a Body Mass Index (BMI) of 18 to 29.9

• provides normal mammogram results within the last year before enrollment for women 40 or older

• is willing and able to comply with all study requirements and return to theinvestigational site for the follow-up procedures and assessments as specified inthis protocol

• Part 2 participants only: has daily access to a smartphone, tablet, or computer withinternet access.

Exclusion Criteria:

Participants will be excluded from participating in this study if they meet any of the following criteria:

• has multiple risk factors for cardiovascular disease (e.g., smoking, diabetes,obesity, hypertension, high LDL (low density lipoprotein), or high triglyceridelevels)

• has current or history of ischemic heart disease or cerebrovascular disease

• has current or previous thromboembolic disorders

• has systemic lupus erythematosus

• has rheumatoid arthritis on immunosuppressive therapy

• has migraine with aura

• has undiagnosed abnormal vaginal bleeding

• has known or suspected breast cancer, history of breast cancer or otherprogestin-sensitive cancer

• has current or history of cervical cancer

• has cirrhosis, liver tumors (benign or malignant), or active liver disease

• has one or more baseline liver function test(s) above the local laboratory's normalrange

• has a hemoglobin <10.5 g/dL

• has used any injectable contraceptive in the past 6 months

• has used any of the following medications within 4 weeks before enrollment:

• any investigational drug

• prohibited drugs (listed in Section 6.3.3.4.4.1 of the study protocol)

• oral contraceptives, contraceptive ring, or patch

• levonorgestrel intrauterine device (LNG IUD) or contraceptive implant

• is pregnant

• is currently breastfeeding

• desires to become pregnant in the subsequent 30 months

• has been pregnant in last 3 months

• is using or planning to use prohibited drugs for their intended study duration

• has abnormal cervical cytology requiring treatment

• has known sensitivity to ENG

• plans to move to another location in the next 30 months

• is participating in any other clinical trial with a biomedical intervention

• has any condition (social or medical), that in the opinion of the site investigatorwould make study participation unsafe, would interfere with adherence to theclinical study requirements, or complicate data interpretation