- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05174884
Casea S Contraceptive Implants (Casea S) Trial
A Phase 1 Clinical Trial to Evaluate the Pharmacokinetics, Removability, Safety, and Tolerability of Casea S Contraceptive Implants
Study Overview
Status
Conditions
Intervention / Treatment
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, eight 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.
Based on PK modeling from Parts 1 and 2, investigators will select one or more doses of Casea S for Part 3. In Part 3 of this study, approximately 18 women will each have Casea S pellets (range 1-3 pellets) 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Kavita Nanda, M.D.
- Phone Number: 919-321-3592
- Email: knanda@fhi360.org
Study Contact Backup
- Name: Brache Vivian, Lic.
- Email: vbrache@gmail.com
Study Locations
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DN
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Santo Domingo, DN, Dominican Republic, 10401
- Recruiting
- Clinica Profamilia
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Contact:
- Vivian Brache
- Email: vbrache@gmail.com
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Principal Investigator:
- Vivian Brache
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 and vital signs tests
- has regular menstrual cycle (21 to 35 days)
- not at risk for pregnancy and not intending future pregnancy (i.e., sterilized)-Part 1 only
- has a low risk of pregnancy (i.e., sterilized, in exclusively same-sex partnership, abstinent, in monogamous relationship with vasectomized partner, using non-hormonal intrauterine device (IUD)-Parts 2 and 3
- has a Body Mass Index (BMI) of 18 to 29, inclusive
- 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 site for the follow-up procedures and assessments as specified in this protocol
- Part 3 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 and on immunosuppressive therapy
- has migraine with aura
- has unexplained vaginal bleeding
- has current or history of breast cancer, or undiagnosed mass detected by breast exam
- has current or history of cervical cancer
- has cirrhosis, liver tumors, or active liver disease
- has a hemoglobin <10.5 g/dL
- has one or more baseline liver function test(s) above the local laboratory's normal range
- 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 (Section 5.5.1)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Subdermal insertion of a single Casea S pellet (22.2 mg ENG) in healthy female participants
Other Names:
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Experimental: Two Casea S pellets
In Part 2 of this study, eight women will each have two Casea S pellets (44.4 mg ENG) inserted into the inner aspect of the non-dominant upper arm.
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Subdermal insertion of a two Casea S pellet (44.4 mg ENG) in healthy female participants
Other Names:
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Experimental: Variable Casea S pellets
Based on PK modeling from Parts 1 and 2, the investigator will select one or more doses of Casea S for Part 3. In Part 3 of this study, approximately 18 women will each have Casea S pellets (range 1-3 pellets) inserted into the inner aspect of the non-dominant upper arm.
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Subdermal insertion of 1-3 Casea S pellets (22.2 - 66.6 mg ENG) in healthy female participants
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum observed serum concentration (Cmax)
Time Frame: 12 weeks; 52 weeks; 130 weeks
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Maximum observed serum concentration (Cmax) measured by blood samples collected at multiple timepoints before and after pellet insertion
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12 weeks; 52 weeks; 130 weeks
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Time to Cmax (tmax)
Time Frame: 12 weeks; 52 weeks; 130 weeks
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Time to Cmax (tmax) measured by blood samples collected at multiple timepoints before and after pellet insertion
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12 weeks; 52 weeks; 130 weeks
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Geometric mean serum ENG concentration
Time Frame: 28 days; 130 weeks
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Geometric mean serum ENG concentration at treatment days 28 and 84
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28 days; 130 weeks
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Area under concentration time curve (AUC 0-28)
Time Frame: 28 days; 154 days; 364 days
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Area under the concentration time curve through days 28 and day 84
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28 days; 154 days; 364 days
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Predicted concentration at day 546 and probability of exceeding 90 pg/mL through day 546
Time Frame: 52 weeks
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pharmacokinetics of ENG after subdermal insertion of 2 Casea S pellets
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52 weeks
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Time to undetectable ENG levels
Time Frame: 130 weeks
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Apparent absorption half-life; Predicted concentration at day 546 and probability of exceeding 90 pg/mL through day 546; Time above 90 pg/mL
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130 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of treatment emergency adverse events, significant changes in vital signs, weight, vaginal bleeding patterns and perceptions, abnormalities in serum chemistry, occurrence of implant site reactions
Time Frame: up to 130 weeks
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Safety and tolerability of Casea S pellets measured by the occurrence of treatment emergency adverse events, significant changes in vital signs, weight, vaginal bleeding patterns and perceptions, abnormalities in serum chemistry, occurrence of implant site reactions
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up to 130 weeks
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Assessment of the ease of insertion of Casea S pellets
Time Frame: up to 130 weeks
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Physician's report of success and ease of insertion.
Ease of insertion qualified as "easy, moderate, or difficult" on the study insertion assessment.
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up to 130 weeks
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Assessment of the duration of Casea S pellets insertion
Time Frame: up to 130 weeks
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Time of the procedure duration
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up to 130 weeks
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Assessment of the complications of insertion of Casea S pellets
Time Frame: up to 130 weeks
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Number and descriptions of the incidence of insertion complications.
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up to 130 weeks
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Ability to completely remove the pellet and ease of removal
Time Frame: up to 130 weeks
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Physician's assessment of the removability of Casea S pellets qualified as "complete removal, partial removal, or not removed" on the study removal assessment.
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up to 130 weeks
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Assessment Casea S pellets removability
Time Frame: up to 130 weeks
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Time of the procedure duration of procedure
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up to 130 weeks
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Assessment of the removability of Casea S pellets
Time Frame: up to 130 weeks
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Number and descriptions of incidence of removal complications
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up to 130 weeks
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Follicular and luteal activity following subdermal insertion of Casea S pellets
Time Frame: up to 130 weeks
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Estradiol (E2) and progesterone (P4) levels
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up to 130 weeks
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Estimate of ENG release rates using explant analysis
Time Frame: up to 130 weeks
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Cumulative amount of ENG released over time, average daily release in 3 months and up to 130 weeks
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up to 130 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kavita Nanda, M.D., FHI 360
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Progestins
- Desogestrel
- Etonogestrel
Other Study ID Numbers
- 1630531
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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