At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,504 enrolled
Drug / intervention
AG200-15 (cycles 1-13) +1 moredrug
Likely dose
Lessina crossover to AG200-15 20 mcgfrom 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.
Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
In Brief
A Phase 3 clinical trial evaluating AG200-15 (cycles 1-13) and Lessina crossover to AG200-15 for Contraception. Completed, enrolled 1,504 participants across 80 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 StartAug 2010
First PostedAug 2010
Primary CompletionDec 2011
Study CompletionMar 2012
TodayJul 2026
First PostedAug 13, 2010
Enrollment StartAug 1, 2010
Primary CompletionDec 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.9 years ago
Interventions
AG200-15 (cycles 1-13)drug
AG200-15 containing ethinyl estradiol and levonorgestrel
Lessina crossover to AG200-15drug
Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.