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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:
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00196365
First received: September 12, 2005
Last updated: January 8, 2010
Last verified: January 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Duramed Research:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Incidence of menstrual bleeding and/or spotting [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Analgesic use [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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, 43213
Duramed Investigational Site
Columbus, Ohio, United States, 43205
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

No publications provided

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00196365     History of Changes
Other Study ID Numbers: DR-PSE-305
Study First Received: September 12, 2005
Last Updated: January 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Duramed Research:
cyclic pelvic pain
dysmenorrhea

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

ClinicalTrials.gov processed this record on October 16, 2012