A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

Last updated: May 9, 2014
Sponsor: Duramed Research
Overall Status: Completed

Phase

3

Condition

Dysmenorrhea (Painful Periods)

Severe Premenstrual Symptom

Menstrual Disorders

Treatment

N/A

Clinical Study ID

NCT00196365
DR-PSE-305
  • Ages 18-40
  • Female

Study Summary

This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Moderate to severe menstrual-related pain

  • Regular spontaneous menstrual cycles

Exclusion

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives

  • Treatment with an oral contraceptive in the last 3 months

  • Previous treatment failure with an extended oral contraceptive regimen

Study Design

Total Participants: 97
Study Start date:
January 01, 2005
Estimated Completion Date:
July 31, 2007

Connect with a study center

  • Duramed Investigational Site

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Duramed Investigational Site

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Duramed Investigational Site

    San Diego, California 92108
    United States

    Site Not Available

  • Duramed Investigational Site

    Denver, Colorado 80202
    United States

    Site Not Available

  • Duramed Investigational Site

    Tampa, Florida 33607
    United States

    Site Not Available

  • Duramed Investigational Site

    Decatur, Georgia 30034
    United States

    Site Not Available

  • Duramed Investigational Site

    Moorestown, New Jersey 08057
    United States

    Site Not Available

  • Duramed Investigational Site

    Charlotte, North Carolina 28222
    United States

    Site Not Available

  • Duramed Investigational Site

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Duramed Investigational Site

    Medford, Oregon 97504
    United States

    Site Not Available

  • Duramed Investigational Site

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Duramed Investigational Site

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Duramed Investigational Site

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Duramed Investigational Site

    Newport News, Virginia 23602
    United States

    Site Not Available

  • Duramed Investigational Site

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Duramed Investigational Site

    Spokane, Washington 99207
    United States

    Site Not Available

  • Duramed Investigational Site

    Tacoma, Washington 98405
    United States

    Site Not Available

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