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Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers

NCT01375946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-07-31

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

AG200-15

There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.

Sponsors & Collaborators

  • Agile Therapeutics

    lead INDUSTRY

Principal Investigators

  • Elizabeth Garner, MD, MPH · Agile Therapeutics

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01375946 on ClinicalTrials.gov