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.
1 other identifier
interventional
109
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2009
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2008
CompletedFirst Posted
Study publicly available on registry
October 29, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
August 29, 2014
CompletedFebruary 6, 2017
December 1, 2016
2.6 years
October 28, 2008
August 19, 2014
December 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period
The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.
Baseline (25-35 days before Day 1) and Days 1-91
Secondary Outcomes (7)
Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months
Baseline, Month1, Month 2 and Month 3
Change From Baseline in Average Migraine Severity
Baseline and Month 1, Month 2 and Month 3
Percentage of Participants Who Required Rescue Medications During the Study Period
Baseline, Month 1, Month 2 and Month 3
Change From Baseline in Migraine Disability Assessment
Baseline and Week 15
Change From Baseline in Headache Impact Test
Baseline and Week 15
- +2 more secondary outcomes
Study Arms (2)
91-day Levonorgestrel Oral Contraceptive
EXPERIMENTALParticipants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
Placebo
PLACEBO COMPARATORParticipants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
Interventions
91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duramed Researchlead
Study Sites (22)
Teva Investigational Site
La Mesa, California, 91942, United States
Duramed Investigational Site
San Diego, California, 92108, United States
Teva Investigational Site
San Diego, California, 92123, United States
Duramed Investigational Site
San Francisco, California, 94109-4841, United States
Duramed Investigational Site
Washington D.C., District of Columbia, 20036, United States
Duramed Investigational Site
West Palm Beach, Florida, 33409, United States
Teva Investigational Site
Savannah, Georgia, 31406, United States
Duramed Investigational Site
Edison, New Jersey, 08817, United States
Duramed Investigational Site
New York, New York, 10022, United States
Teva Investigational Site
Winston-Salem, North Carolina, 27103, United States
Teva Investigational Site
Tulsa, Oklahoma, 74105, United States
Teva Investigational Site
Medford, Oregon, 97504, United States
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114, United States
Teva Investigational Site
Uniontown, Pennsylvania, 15401, United States
Teva Investigational Site
Columbia, South Carolina, 29201, United States
Teva Investigational Site
Hilton Head, South Carolina, 29926, United States
Teva Investigational Site
Memphis, Tennessee, 38120, United States
Duramed Investigational Site
Dallas, Texas, 75234, United States
Teva Investigational Site
Houston, Texas, 77054, United States
Duramed Investigational Site
San Antonio, Texas, 78258, United States
Duramed Investigational Site
Virginia Beach, Virginia, 23454, United States
Duramed Investigational Site
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc.
Study Officials
- STUDY CHAIR
Duramed Research Protocol Chair
Duramed Research, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2008
First Posted
October 29, 2008
Study Start
January 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
February 6, 2017
Results First Posted
August 29, 2014
Record last verified: 2016-12