A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches
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.
Drug: 91-day Levonorgestrel Oral Contraceptive
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|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.|
- Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period [ Time Frame: Baseline (25-35 days before Day 1) and Days 1-91 ] [ Designated as safety issue: No ]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.
- Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months [ Time Frame: Baseline, Month1, Month 2 and Month 3 ] [ Designated as safety issue: No ]The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.
- Change From Baseline in Average Migraine Severity [ Time Frame: Baseline and Month 1, Month 2 and Month 3 ] [ Designated as safety issue: No ]
Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication.
Average migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity.
- Percentage of Participants Who Required Rescue Medications During the Study Period [ Time Frame: Baseline, Month 1, Month 2 and Month 3 ] [ Designated as safety issue: No ]Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.
- Change From Baseline in Migraine Disability Assessment [ Time Frame: Baseline and Week 15 ] [ Designated as safety issue: No ]
The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months.
The MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities).
The MIDAS score is classified into four grades of severity:
- 0 to 5: MIDAS Grade I, Little or no disability
- 6 to 10: MIDAS Grade II, Mild disability
- 11 to 20: MIDAS Grade III, Moderate disability
- 21+: MIDAS Grade IV, Severe disability
- Change From Baseline in Headache Impact Test [ Time Frame: Baseline and Week 15 ] [ Designated as safety issue: No ]
The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations.
HIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life.
There was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated.
- Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 15 weeks ] [ Designated as safety issue: Yes ]
An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study.
The following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity.
Relationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain.
A serious adverse event (SAE) is one that met any one of the following criteria:
- Fatal or life threatening
- Requires or prolongs in patient hospitalization
- Results in persistent or significant disability/incapacity
- Congenital anomaly / birth defect
- Important medical event.
- Mean Number of Days of Bleeding or Spotting [ Time Frame: 91-day treatment period ] [ Designated as safety issue: Yes ]Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.
|Study Start Date:||January 2009|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: 91-day Levonorgestrel Oral Contraceptive
Participants 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.
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.
Placebo Comparator: Placebo
Participants 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.
1 tablet daily to match experimental arm
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781456
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|Study Chair:||Duramed Research Protocol Chair||Duramed Research, Inc.|