Long Term Evaluation of Scapular-inserted Contraceptive Implants

ConditionContraception

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorYale University

About this trial

This study aims to evaluate long-term outcomes when the etonogestrel contraceptive implant is inserted at an alternative site located over the scapular. The study will evaluate the pharmacokinetics (i.e., drug levels) and side effect profiles of participants who have an etonogestrel contraceptive implant inserted at this alternative scapular site over the course of at least two years.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Sex assigned at birth must be Female

Aged 18-45 years

Disqualifiers

Self-reported contraindications to the use of the ENG implant based on the CDC Medical Eligibility Criteria guidelines for any conditions with a category 3 or 4 recommendation

Current breast cancer or personal history of breast cancer

Malignant liver tumor (hepatocellular carcinoma)

Allergic reaction to any components of the ENG implant

Trial design

Design model

Single group

Treatments tested in this trial

Scapular-site insertion of etonogestrel contraceptive implant
Drug
Participants will undergo insertion of the etonogestrel contraceptive implant subdermally over the inferior edge of their non-dominant scapula

Treatment groups

62 Participants

are divided into 1 treatment group

Group A: Reproductive age femalesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Serum etonogestrel concentrations

Serum etonogestrel concentrations measured using a validated LC-MS assay

Time frame

Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years)

Secondary outcomes

Progestin-related side effects

Assessment of common progestin-related side effects (e.g., nausea, headaches, bloating) using a questionnaire

Time frame

Every 6 months after insertion of the etonogestrel contraceptive implant for up to 36 months (3 years)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

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