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New birth control implant shows promise in early safety trial

NCT ID NCT05174884

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new contraceptive implant called Casea S in 20 healthy women. The goal is to check how the body processes the hormone, how easy it is to remove, and if it's safe. The implant aims to prevent pregnancy for at least 78 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clinica Profamilia

    Santo Domingo, DN, 10401, Dominican Republic

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