A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy of DR-105 Compared to Placebo For the Management of Menstrually-Related Migraine Headaches.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Duramed Research
- Enrollment
- 109
- Locations
- 2
- Primary Endpoint
- Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 34 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: 91-day Levonorgestrel Oral Contraceptive (Drug)
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- 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)
- Number of Participants With Adverse Events (AEs)(Up to 15 weeks)
- Mean Number of Days of Bleeding or Spotting(91-day treatment period)