Trials / Completed
CompletedNCT00781456
A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy of DR-105 Compared to Placebo For the Management of Menstrually-Related Migraine Headaches.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Duramed Research · Industry
- Sex
- Female
- Age
- 18 Years – 34 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 91-day Levonorgestrel Oral Contraceptive | 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE. |
| DRUG | Placebo | 1 tablet daily to match experimental arm |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2008-10-29
- Last updated
- 2017-02-06
- Results posted
- 2014-08-29
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00781456. Inclusion in this directory is not an endorsement.