At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 109 enrolled
Drug / intervention
91-day Levonorgestrel Oral Contraceptive +1 moredrug
Likely dose
91-day Levonorgestrel Oral Contraceptive 150 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.
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy of DR-105 Compared to Placebo For the Management of Menstrually-Related Migraine Headaches.
In Brief
A Phase 2 clinical trial evaluating 91-day Levonorgestrel Oral Contraceptive and Placebo for Migraine. Completed, enrolled 109 participants across 22 sites.
Detailed Summary
This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral contraceptive compared to placebo for decreasing the frequency and severity of menstrually-related migraine headaches.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartJan 2009
Primary CompletionAug 2011
TodayJul 2026
First PostedOct 29, 2008
Enrollment StartJan 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.7 years ago
Interventions
91-day Levonorgestrel Oral Contraceptivedrug
91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.
Placebodrug
1 tablet daily to match experimental arm