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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); Placebo tablet (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Duramed Research

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 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.

Clinical Details

Official title: A Multicenter Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval to Placebo for the Treatment of Cyclic Pelvic Pain in Adolescents

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

Primary outcome: Mean Change in Average Severity for Abdominal/Pelvic Pain

Secondary outcome:

Maximum Severity of Abdominal/Pelvic Pain

Incidence of Menstrual Bleeding and /or Spotting

Number of Days Missed From School/Work or Other Activities

Analgesic Use

Eligibility

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Sexually naïve and agree to abstain from sex during the study

- Moderate to severe menstrual-related pelvic pain

- Regular spontaneous menstrual cycles

Exclusion Criteria:

- Any contraindication to the use of oral contraceptives

- Treatment with an oral contraceptive within the previous 3 months

- Previous treatment failure with an extended oral contraceptive regimen

Locations and Contacts

Duramed Investigational Site, Denver, Colorado 80218-1088, United States

Duramed Investigational Site, Decatur, Georgia 30034, United States

Duramed Investigational Site, Louisville, Kentucky 40202, United States

Duramed Investigational Site, St. Louis, Missouri 63110, United States

Duramed Investigational Site, Cincinatti, Ohio 45229, United States

Duramed Investigational Site, Cleveland, Ohio 44109, 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, Pittsburgh, Pennsylvania 15213, United States

Duramed Investigational Site, Willow Grove, Pennsylvania 19090, United States

Duramed Investigational Site, Providence, Rhode Island 02903, United States

Duramed Investigational Site, Salt Lake City, Utah 84124, United States

Additional Information

Starting date: May 2005
Last updated: April 25, 2012

Page last updated: August 23, 2015

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