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

This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research ) Identifier:
First received: September 12, 2005
Last updated: August 16, 2016
Last verified: August 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:

Further study details as provided by Teva Pharmaceutical Industries ( Duramed Research ):

Primary Outcome Measures:
  • Mean Change in Average Severity for Abdominal/Pelvic Pain [ Time Frame: Baseline to end of 13-week treatment period ]
    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:
  • Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain [ Time Frame: Baseline to end of Week 13 ]

    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 ]
  • Number of Days Missed From School/Work or Other Activities [ Time Frame: 13-week treatment period ]
  • Analgesic Use [ Time Frame: 13-week treatment period ]
    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 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet 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


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00196313

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

Responsible Party: Duramed Research 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: August 16, 2016

Keywords provided by Teva Pharmaceutical Industries ( Duramed Research ):
cyclic pelvic pain
oral contraceptives

Additional relevant MeSH terms:
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Menstruation Disturbances
Pathologic Processes
Contraceptive Agents
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined processed this record on July 19, 2017