CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
AG200-15drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01375946
NCT01375946Phase 1Completed
CompareCT.gov

A Pharmacokinetic And Wearability Study of the Agile TCDS AG200-15 Following Weekly Application Under Various External Conditions in Healthy Female Volunteers

Agile Therapeutics·interventional·Posted Jun 20, 2011·Updated Jul 31, 2018

In Brief

A Phase 1 clinical trial evaluating AG200-15 for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 20, 2011
Enrollment StartMay 1, 2011
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.0 years ago

Interventions

AG200-15drug

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.