Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will be evaluated.
To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation), and safety of AG890-6.5 and AG890-12.5 TCDS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
transdermal contraceptive delivery system
Levonorgestrel Pharmacokinetic Profile
The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.
Time frame: 8 weeks
Evaluation of Patch Adhesion
Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale: 0: ≥90% adhered (no lift) 1. ≥75% adhered but \<90% (some edges showing lift) 2. ≥50% adhered but \<75% (half of system lifts off) 3. \<50% (\< half of system lifts off, but undetached) 4. patch completely detached
Time frame: 8 weeks
Evaluation of Irritation at Patch Application Site
Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale: 0: None 1. Mild 2. Moderate 3. Severe
Time frame: 8 weeks
Evaluation of Itching at Patch Application Site
Self-reported worst skin itching at patch application site by subject using a 4-point scale: 0\. None 1. Mild 2. Moderate 3. Severe
Time frame: 8 weeks
Cycle Control
Measurement of unscheduled bleeding/spotting days.
Time frame: 8 weeks
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