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.”

This study is being conducted to evaluate the efficacy of DR-105 compared to placebo for decreasing the frequency and severity of menstrually-related migraine headaches.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2009

This is a multicenter, randomized, study to evaluate and compare the frequency and severity of menstrually-related migraine headaches before and during the 7-day ethinyl estradiol monotherapy interval in women treated with DR-105 compared to placebo during the 91-day treatment period.

Intervention(s) in this Clinical Trial

• Drug: DR-105
  • Levonorgestrel [LNG]/ethinyl estradiol [EE] 0.15/0.03 mg for 84 days and EE 0.01 mg tablets for 7 days 1 tablet daily
• Other: Placebo
  • 1 tablet daily to match experimental arm

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Portion of subjects with ≥ 50% reduction in migraine frequency during the treatment period compared to baseline
  • Time Frame: Duration of Study
    Safety Issue?: No

Secondary Measures

• Portion of subjects with ≥ 50% reduction in migraine frequency during the first, second and third month of the study compared to baseline
  • Time Frame: Duration of study
    Safety Issue?: No
• Change in migraine severity during the first, second and thrid month of the study, and the whole 91-day treatment period.
  • Time Frame: Duration of Study
    Safety Issue?: No
• Incidence and use of rescue medications during the study period.
  • Time Frame: Baseline to end of treatment period
    Safety Issue?: No
• Incidence of adverse events
  • Time Frame: Duration of study
    Safety Issue?: Yes
• Incidence of bleeding and spotting
  • Time Frame: Duration of the study
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 34 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Duramed Research Protocol Chair Study Chair Duramed Research, Inc.  

Overall Contact: C M O'Leary, Pharm.D. 610-747-2679 medicalaffairs@barrlabs.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00781456

Study ID Number: DR-105-201

ClinicalTrials.gov Identifier: NCT00781456

Health Authority: United States: Food and Drug Administration