At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 407 enrolled
Drug / intervention
AG200-15 +1 moredrug
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.
An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE
In Brief
A Phase 3 clinical trial evaluating AG200-15 and Levora for Contraception. Completed, enrolled 407 participants across 21 sites.
Detailed Summary
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
First PostedNov 2010
Primary CompletionJun 2011
TodayJul 2026
First PostedNov 9, 2010
Enrollment StartOct 1, 2010
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.6 years ago
Interventions
AG200-15drug
Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
Levoradrug
One tablet of Levora will be taken each day for a 28 day cycle.