A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Information source: Duramed Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dysmenorrhea
Intervention: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets (Drug); levonorgestrel/EE 0.15/0.03 mg tablets and placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Duramed Research Official(s) and/or principal investigator(s):
Duramed Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc.
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.
Clinical Details
Official title: A Study to Compare the Efficacy of an Extended-Cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-Free Interval Compared to Conventional Oral Contraceptive Therapy for Cyclic Pelvic Pain
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in the clinical assessment of dysmenorrhea
Secondary outcome: Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)Incidence of menstrual bleeding and/or spotting Analgesic use
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Moderate to severe menstrual-related pain
- Regular spontaneous menstrual cycles
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
Locations and Contacts
Duramed Investigational Site, Huntsville, Alabama 35801, United States
Duramed Investigational Site, Phoenix, Arizona 85032, United States
Duramed Investigational Site, San Diego, California 92108, United States
Duramed Investigational Site, Denver, Colorado 80202, United States
Duramed Investigational Site, Tampa, Florida 33607, United States
Duramed Investigational Site, Decatur, Georgia 30034, United States
Duramed Investigational Site, Moorestown, New Jersey 08057, United States
Duramed Investigational Site, Charlotte, North Carolina 28222, United States
Duramed Investigational Site, Columbus, Ohio 43213, United States
Duramed Investigational Site, Columbus, Ohio 43205, United States
Duramed Investigational Site, Medford, Oregon 97504, United States
Duramed Investigational Site, Philadelphia, Pennsylvania 19114, United States
Duramed Investigational Site, Memphis, Tennessee 38120, United States
Duramed Investigational Site, Salt Lake City, Utah 84124, United States
Duramed Investigational Site, Norfolk, Virginia 23507, United States
Duramed Investigational Site, Newport News, Virginia 23602, United States
Duramed Investigational Site, Spokane, Washington 99207, United States
Duramed Investigational Site, Tacoma, Washington 98405, United States
Additional Information
Starting date: January 2005
Ending date: July 2007
Last updated: February 29, 2008
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