A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day: Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily
University of Colorado Denver
Aurora, Colorado, United States
Serum Etonogestrel Concentrations
The investigators will collect serum from participants at enrollment and at each of the three study follow-up visits. All samples will be batched for analysis. Analysis will be performed using a liquid-chromatography mass-spectrometry validated assay for measurement of serum etonogestrel concentration.
Time frame: Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)
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