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A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: 91-day Levonorgestrel Oral Contraceptive (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Duramed Research

Official(s) and/or principal investigator(s):
Duramed Research Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc.

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period

Secondary outcome:

Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months

Change From Baseline in Average Migraine Severity

Percentage of Participants Who Required Rescue Medications During the Study Period

Change From Baseline in Migraine Disability Assessment

Change From Baseline in Headache Impact Test

Number of Participants With Adverse Events (AEs)

Mean Number of Days of Bleeding or Spotting

Eligibility

Minimum age: 18 Years. Maximum age: 34 Years. Gender(s): Female.

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

Locations and Contacts

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, 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

Additional Information

Starting date: January 2009
Last updated: August 19, 2014

Page last updated: August 23, 2015

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