Phase 2
Completed N=109
A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches
Source: ClinicalTrials.gov NCT00781456 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period — 48.1; 48.9 percentage of participants — p=0.954
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period |
48.1; 48.9 | 0.954 |
| SECONDARY Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months |
42.6; 37.8; 62.7; 52.3; 60.0; 64.9 | 0.479 |
| SECONDARY Change From Baseline in Average Migraine Severity |
-0.37; -0.18; -0.55; -0.52; -0.98; -0.72 | 0.182 |
| SECONDARY Percentage of Participants Who Required Rescue Medications During the Study Period |
85.2; 75.6; 63.0; 55.6; 45.1; 54.5 | 0.457 |
| SECONDARY Change From Baseline in Migraine Disability Assessment |
-7.8; -8.5 | — |
| SECONDARY Change From Baseline in Headache Impact Test |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
32; 17; 11; 2; 17; 10 | — |
| SECONDARY Mean Number of Days of Bleeding or Spotting |
21.2; 15.5 | — |
Eligibility Criteria
Inclusion Criteria
- Premenopausal, non-pregnant, non-lactating
- History of migraine headaches without aura for at least 6 months
- History of migraine headaches associated with menstruation
- Others as directed by FDA-approved protocol
Exclusion Criteria
- History of migraine headaches with aura or focal neurological symptoms
- Any contraindication to the use of oral contraceptives
- Others as dictated by FDA-approved protocol
Data sourced from ClinicalTrials.gov (NCT00781456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.