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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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 43205, United States

Duramed Investigational Site, Columbus, Ohio 43213, 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, Newport News, Virginia 23602, United States

Duramed Investigational Site, Norfolk, Virginia 23507, United States

Duramed Investigational Site, Spokane, Washington 99207, United States

Duramed Investigational Site, Tacoma, Washington 98405, United States

Additional Information

Starting date: January 2005
Last updated: May 9, 2014

Page last updated: August 23, 2015

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