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A Multicenter Study to Evaluate the Efficacy of DR-105 for Menstrually-Related Migraine Headaches

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00781456
First received: October 28, 2008
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Migraine
 Drug: Seasonique
Drug: Placebo
 Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Portion of subjects with ≥ 50% reduction in migraine frequency during the treatment period compared to baseline [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • Change in migraine severity during the first, second and third month of the study, and the whole 91-day treatment period. [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
  • Incidence and use of rescue medications during the study period. [ Time Frame: Baseline to end of treatment period ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • Incidence of bleeding and spotting [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]

Enrollment: 109
Study Start Date: November 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Seasonique

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 Names:
  • Seasonique [LNG/EE and EE]
  • DR-105
Placebo Comparator: 2 Drug: Placebo
1 tablet daily to match experimental arm

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781456

  Show 22 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Research Protocol Chair Duramed Research, Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00781456     History of Changes
Other Study ID Numbers: DR-105-201
Study First Received: October 28, 2008
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Migraine headache
menstrual
oral contraceptive
Menstrually-Related Migraine Headache

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
 Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013