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
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
Treatments tested in this trial
- Scapular-site insertion of etonogestrel contraceptive implant
Treatment groups
62 Participants
are divided into 1 treatment groupSponsors and collaborators
Yale University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov