At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Ortho-Cyclen +1 moredrug
Likely dose
Ortho-Cyclen 35 µgfrom 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 Study to Evaluate Pharmacokinetic Profile of Agile TCDS AG200-15 and to Compare Exposure to Ethinyl Estradiol to Oral Contraceptive (Orthocyclen®) in Healthy Female Volunteers
In Brief
A Phase 1 clinical trial evaluating Ortho-Cyclen and AG200-15 for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
Primary CompletionDec 2009
First PostedNov 2010
TodayJul 2026
First PostedNov 18, 2010
Enrollment StartAug 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.6 years ago
Interventions
Ortho-Cyclendrug
Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.
AG200-15drug
AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE