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ContraceptionPhase 1NCT05174884

Casea S Contraceptive Implants (Casea S) Trial

A Phase 1 study testing 22.2 mg Etonogestrel (ENG) and 44.4 mg Etonogestrel (ENG) in people with Contraception, run by FHI 360 at 1 site in Dominican Republic.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
22.2 mg Etonogestrel (ENG) and 44.4 mg Etonogestrel (ENG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDominican Republic
Study dates
13 Dec 2023to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site

  • Clinica Profamilia

    Santo Domingo, DN, 10401

Other trials in Dominican Republic

About this study

Official title: A Phase 1 Clinical Trial to Evaluate the Pharmacokinetics, Removability, Safety, and Tolerability of Casea S Contraceptive Implants

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.

Read the 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
Being tested
22.2 mg Etonogestrel (ENG), 44.4 mg Etonogestrel (ENG)
Keywords
Long Acting Reversible Contraceptive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 22.2 mg Etonogestrel (ENG)Drug

    Also called Casea S

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

  • 44.4 mg Etonogestrel (ENG)Drug

    Also called Casea S

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

Study groups in NCT05174884
Study groupRoleWhat they receive
Single Casea S pelletExperimentalIn 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.
Receives: Drug: 22.2 mg Etonogestrel (ENG)
Two Casea S pelletsExperimentalIn 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.
Receives: Drug: 44.4 mg Etonogestrel (ENG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed serum concentration (Cmax)

    Maximum observed serum concentration (Cmax) measured by blood samples collected at multiple timepoints before and after pellet insertion

    Measured: 12 weeks; 52 weeks; 114 weeks

  2. Time to Cmax (tmax)

    Time to Cmax (tmax) measured by blood samples collected at multiple timepoints before and after pellet insertion

    Measured: 12 weeks; 52 weeks; 114 weeks

  3. Geometric mean serum ENG concentration

    Geometric mean serum ENG concentration at treatment days 28 and 84

    Measured: 28 days; 84 days; 114 weeks

  4. Area under concentration time curve (AUC 0-28)

    Area under the concentration time curve through days 28 and day 84

    Measured: 28 days; 84 days; 154 days; 364 days

  5. Predicted concentration at day 546 and probability of exceeding 90 pg/mL through day 546

    pharmacokinetics of ENG after subdermal insertion of 2 Casea S pellets

    Measured: 52 weeks

  6. Assessment of the removability of Casea S pellets

    Number and descriptions of incidence of removal complications

    Measured: up to 26 weeks

  7. Assessment Casea S pellets removability

    Time of the procedure duration of procedure

    Measured: up to 26 weeks

  8. Ability to completely remove the pellet and ease of removal

    Physician's assessment of the removability of Casea S pellets qualified as "complete removal, partial removal, or not removed" on the study removal assessment.

    Measured: up to 26 weeks

  9. Time to undetectable ENG levels

    Apparent absorption half-life; Predicted concentration at day 546 and probability of exceeding 90 pg/mL through day 546; Time above 90 pg/mL

    Measured: 114 weeks

Secondary outcomes (6)

  1. Occurrence of treatment emergent adverse events, significant changes in vital signs, weight, vaginal bleeding patterns and perceptions, abnormalities in serum chemistry, occurrence of implant site reactions

    Safety and tolerability of Casea S pellets measured by the occurrence of treatment emergent adverse events, significant changes in vital signs, weight, vaginal bleeding patterns and perceptions, abnormalities in serum chemistry, occurrence of implant site reactions

    Measured: up to 114 weeks

  2. Assessment of the ease of insertion of Casea S pellets

    Physician's report of success and ease of insertion. Ease of insertion qualified as "easy, moderate, or difficult" on the study insertion assessment.

    Measured: up to 114 weeks

  3. Assessment of the duration of Casea S pellets insertion

    Time of the procedure duration

    Measured: up to 114 weeks

  4. Assessment of the complications of insertion of Casea S pellets

    Number and descriptions of the incidence of insertion complications.

    Measured: up to 114 weeks

  5. Follicular and luteal activity following subdermal insertion of Casea S pellets

    Estradiol (E2) and progesterone (P4) levels

    Measured: up to 114 weeks

  6. Estimate of ENG release rates using explant analysis

    Cumulative amount of ENG released over time, average daily release in 3 months and up to 130 weeks

    Measured: up to 114 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2022
  2. Study start13 Dec 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05174884
Sponsor's protocol ID
1630531
Status last verified
Apr 2026
First submitted
25 Aug 2021
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 22.2 mg Etonogestrel (ENG) and 44.4 mg Etonogestrel (ENG) in people with Contraception, run by FHI 360 at 1 site in Dominican Republic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed serum concentration (Cmax) (time frame: 12 weeks; 52 weeks; 114 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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