NCT05174884

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
13mo left

Started Dec 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Dec 2023Jun 2027

First Submitted

Initial submission to the registry

August 25, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
1.9 years until next milestone

Study Start

First participant enrolled

December 13, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

August 25, 2021

Last Update Submit

April 2, 2026

Conditions

Contraception

Keywords

Long Acting Reversible Contraceptive

Outcome Measures

Primary Outcomes (9)

  • Maximum observed serum concentration (Cmax)

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

    12 weeks; 52 weeks; 114 weeks

  • Time to Cmax (tmax)

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

    12 weeks; 52 weeks; 114 weeks

  • Geometric mean serum ENG concentration

    Geometric mean serum ENG concentration at treatment days 28 and 84

    28 days; 84 days; 114 weeks

  • Area under concentration time curve (AUC 0-28)

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

    28 days; 84 days; 154 days; 364 days

  • 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

    52 weeks

  • Assessment of the removability of Casea S pellets

    Number and descriptions of incidence of removal complications

    up to 26 weeks

  • Assessment Casea S pellets removability

    Time of the procedure duration of procedure

    up to 26 weeks

  • 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.

    up to 26 weeks

  • 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

    114 weeks

Secondary Outcomes (6)

  • 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

    up to 114 weeks

  • Assessment of the ease of insertion of Casea S pellets

    up to 114 weeks

  • Assessment of the duration of Casea S pellets insertion

    up to 114 weeks

  • Assessment of the complications of insertion of Casea S pellets

    up to 114 weeks

  • Follicular and luteal activity following subdermal insertion of Casea S pellets

    up to 114 weeks

  • +1 more secondary outcomes

Study Arms (2)

Single Casea S pellet

EXPERIMENTAL

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.

Drug: 22.2 mg Etonogestrel (ENG)

Two Casea S pellets

EXPERIMENTAL

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.

Drug: 44.4 mg Etonogestrel (ENG)

Interventions

22.2 mg Etonogestrel (ENG)DRUG

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

Also known as: Casea S
Single Casea S pellet
44.4 mg Etonogestrel (ENG)DRUG

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

Also known as: Casea S
Two Casea S pellets

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Profamilia

Santo Domingo, DN, 10401, Dominican Republic

Location

MeSH Terms

Interventions

etonogestrel

Study Officials

  • Kavita Nanda, M.D.

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

January 3, 2022

Study Start

December 13, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DO(1)