Phase 1
Completed N=24
Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers
Healthy
Source: ClinicalTrials.gov NCT01375946 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG) — 157; 118; 153; 137 ng*hr/mL
Summary
A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG) |
157; 118; 153; 137; 119 | — |
| PRIMARY AUC(0-168) Profile of Ethinyl Estradiol (EE) |
4.7; 4.3; 4.9; 4.3; 3.9 | — |
| PRIMARY Steady-state Concentration (Css) (48-168) Profile of LNG |
1068; 793; 1033; 918; 814 | — |
| PRIMARY Css (48-168) Profile of EE |
30; 28; 29; 27; 24 | — |
| SECONDARY Patch Adhesion |
0.08; 0.08; 0; 0; 0.17 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy women, ages 18-45
- Body mass index (BMI)of ≥18 and less than or equal to 32, and weight ≥ 110 lbs.
- Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy
- Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period
- Willing to give informed consent to participate in study
Exclusion Criteria
- Known or suspected pregnancy
- Breast-feeding or within 1 month after stopping breast-feeding
- Smokers
- Any disease that may worsen with hormonal treatment
- Hypersensitivity to transdermal preparations or sensitivity to surgical/medical tape
Data sourced from ClinicalTrials.gov (NCT01375946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.