Clinical trial NCT00781456: A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches
Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy of DR-105 Compared to Placebo For the Management of Menstrually-Related Migraine Headaches.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: Migraine headache
menstrual
oral contraceptive
Menstrually-Related Migraine Headache
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period
timeFrame: Baseline (25-35 days before Day 1) and Days 1-91
Secondary outcomes:
measure: Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months
timeFrame: Baseline, Month1, Month 2 and Month 3
measure: Change From Baseline in Average Migraine Severity
timeFrame: Baseline and Month 1, Month 2 and Month 3
measure: Percentage of Participants Who Required Rescue Medications During the Study Period
timeFrame: Baseline, Month 1, Month 2 and Month 3
measure: Change From Baseline in Migraine Disability Assessment
timeFrame: Baseline and Week 15
measure: Change From Baseline in Headache Impact Test
timeFrame: Baseline and Week 15
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 15 weeks
measure: Mean Number of Days of Bleeding or Spotting
timeFrame: 91-day treatment period
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Teva Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Teva Investigational Site
state: California
city: San Francisco
country: United States
facility: Duramed Investigational Site
state: California
city: Washington
country: United States
facility: Duramed Investigational Site
state: District of Columbia
city: West Palm Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: Savannah
country: United States
facility: Teva Investigational Site
state: Georgia
city: Edison
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: New York
country: United States
facility: Duramed Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Teva Investigational Site
state: North Carolina
city: Tulsa
country: United States
facility: Teva Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Teva Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Teva Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Teva Investigational Site
state: South Carolina
city: Hilton Head
country: United States
facility: Teva Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Teva Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: Virginia Beach
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Duramed Investigational Site
state: Washington
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Research Protocol Chair
role: STUDY_CHAIR
References: