Casea S Contraceptive Implants (Casea S) Trial

NCT ID: NCT05174884

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-13
• Study Completion Date: 2027-06-30

Brief Summary

This is a single-center, two-part, Phase 1 study to evaluate the pharmacokinetics (PK) of ENG, removability, safety, and tolerability of Casea S pellets inserted subdermally in healthy women of reproductive age. The goal is to select for further investigation a dose of Casea S that is both safe and has a PK profile consistent with contraceptive protection for at least 78 weeks.

Detailed Description

In Part 1 of this study, four women will each have a single Casea S pellet (22.2 mg ENG) inserted into the inner aspect of the non-dominant upper arm after a negative urine pregnancy test. The insertion site and pellet location will be verified, marked, and photographed. ISRs and AEs will be assessed.

In Part 2 of this study, approximately sixteen women will each have two Casea S pellets (44.4 mg ENG) inserted into the inner aspect of the non-dominant upper arm. The insertion site and pellet location will be verified, marked, and photographed. ISRs and AEs will be assessed.

Conditions

Contraception

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Single Casea S pellet

In Part 1 of this study, four women will each have a single Casea S pellet (22.2 mg ENG) inserted into the inner aspect of the non-dominant upper arm.

Group Type: EXPERIMENTAL

22.2 mg Etonogestrel (ENG)

Intervention Type: DRUG

Subdermal insertion of a single Casea S pellet (22.2 mg ENG) in healthy female participants

Two Casea S pellets

In Part 2 of this study, sixteen women will each have two Casea S pellets (44.4 mg ENG) inserted into the inner aspect of the non-dominant upper arm.

Group Type: EXPERIMENTAL

44.4 mg Etonogestrel (ENG)

Intervention Type: DRUG

Subdermal insertion of a two Casea S pellet (44.4 mg ENG) in healthy female participants

Interventions

22.2 mg Etonogestrel (ENG)

Subdermal insertion of a single Casea S pellet (22.2 mg ENG) in healthy female participants

Intervention Type: DRUG

44.4 mg Etonogestrel (ENG)

Subdermal insertion of a two Casea S pellet (44.4 mg ENG) in healthy female participants

Intervention Type: DRUG

Other Intervention Names

Casea S; Casea S

Eligibility Criteria

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, vital signs, 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 the investigational site for the follow-up procedures and assessments as specified in this protocol
• Part 2 participants only: has daily access to a smartphone, tablet, or computer with internet 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 triglyceride levels)
• 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 other progestin-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 normal range
• 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 investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements, or complicate data interpretation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kavita Nanda, M.D.

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Locations

Clinica Profamilia

Santo Domingo, DN, Dominican Republic

Countries

Dominican Republic

Other Identifiers

1630531

Identifier Type: -

Identifier Source: org_study_id