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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 (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00196313
First received: September 12, 2005
Last updated: April 25, 2012
Last verified: April 2012
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 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.


Condition Intervention Phase
Dysmenorrhea
 Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
Drug: Placebo tablet
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Mean Change in Average Severity for Abdominal/Pelvic Pain [ Time Frame: Baseline to end of 13-week treatment period ] [ Designated as safety issue: No ]
    Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")


Secondary Outcome Measures:
  • Maximum Severity of Abdominal/Pelvic Pain [ Time Frame: Baseline to end of Week 13 ] [ Designated as safety issue: No ]

    Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13.

    The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")


  • Incidence of Menstrual Bleeding and /or Spotting [ Time Frame: Baseline to end of Week 13 ] [ Designated as safety issue: No ]
  • Number of Days Missed From School/Work or Other Activities [ Time Frame: 13-week treatment period ] [ Designated as safety issue: No ]
  • Analgesic Use [ Time Frame: 13-week treatment period ] [ Designated as safety issue: No ]
    number of days analgesic (pain) medication was used over the 13 week treatment period


Enrollment: 95
Study Start Date: May 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (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 by mouth
Other Name: Seasonique
Placebo Comparator: 2 Drug: Placebo tablet
1 tablet daily by mouth

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196313

Locations
United States, Colorado
Duramed Investigational Site
Denver, Colorado, United States, 80218-1088
United States, Georgia
Duramed Investigational Site
Decatur, Georgia, United States, 30034
United States, Kentucky
Duramed Investigational Site
Louisville, Kentucky, United States, 40202
United States, Missouri
Duramed Investigational Site
St. Louis, Missouri, United States, 63110
United States, Ohio
Duramed Investigational Site
Cincinatti, Ohio, United States, 45229
Duramed Investigational Site
Cleveland, Ohio, United States, 44109
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
Duramed Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Duramed Investigational Site
Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
Duramed Investigational Site
Providence, Rhode Island, United States, 02903
United States, Utah
Duramed Investigational Site
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Duramed Research
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00196313     History of Changes
Other Study ID Numbers: DR-PSE-306
Study First Received: September 12, 2005
Results First Received: October 12, 2011
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
cyclic pelvic pain
dysmenorrhea
oral contraceptives

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

ClinicalTrials.gov processed this record on May 21, 2013