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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196365
First Posted: September 20, 2005
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Teva Pharmaceutical Industries
  Purpose
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.

Condition Intervention Phase
Dysmenorrhea Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change from baseline in the clinical assessment of dysmenorrhea [ Time Frame: Baseline to Week 4,8,12,24, and 26 or early discontinuation ]

Secondary Outcome Measures:
  • Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms) [ Time Frame: Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation ]
  • Incidence of menstrual bleeding and/or spotting [ Time Frame: Duration of study ]
  • Analgesic use [ Time Frame: Duration of study ]

Enrollment: 97
Study Start Date: January 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
1 tablet daily
Other Name: Seasonique
Active Comparator: 2 Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo
1 tablet daily
Other Name: Portia

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196365


Locations
United States, Alabama
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Duramed Investigational Site
Phoenix, Arizona, United States, 85032
United States, California
Duramed Investigational Site
San Diego, California, United States, 92108
United States, Colorado
Duramed Investigational Site
Denver, Colorado, United States, 80202
United States, Florida
Duramed Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Duramed Investigational Site
Decatur, Georgia, United States, 30034
United States, New Jersey
Duramed Investigational Site
Moorestown, New Jersey, United States, 08057
United States, North Carolina
Duramed Investigational Site
Charlotte, North Carolina, United States, 28222
United States, Ohio
Duramed Investigational Site
Columbus, Ohio, United States, 43205
Duramed Investigational Site
Columbus, Ohio, United States, 43213
United States, Oregon
Duramed Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Duramed Investigational Site
Philadelphia, Pennsylvania, United States, 19114
United States, Tennessee
Duramed Investigational Site
Memphis, Tennessee, United States, 38120
United States, Utah
Duramed Investigational Site
Salt Lake City, Utah, United States, 84124
United States, Virginia
Duramed Investigational Site
Newport News, Virginia, United States, 23602
Duramed Investigational Site
Norfolk, Virginia, United States, 23507
United States, Washington
Duramed Investigational Site
Spokane, Washington, United States, 99207
Duramed Investigational Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
  More Information

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00196365     History of Changes
Other Study ID Numbers: DR-PSE-305
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: May 12, 2014
Last Verified: May 2014

Keywords provided by Teva Pharmaceutical Industries:
cyclic pelvic pain
dysmenorrhea

Additional relevant MeSH terms:
Pelvic Pain
Dysmenorrhea
Pain
Neurologic Manifestations
Signs and Symptoms
Menstruation Disturbances
Pathologic Processes
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined