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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:
NCT00196313
First Posted: September 20, 2005
Last Update Posted: September 22, 2016
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 (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
  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
Intervention Model: Parallel Assignment
Masking: Double (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

  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:   up to 17 Years   (Child)
Sexes 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
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): 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

Responsible Party: Duramed Research
ClinicalTrials.gov Identifier: NCT00196313     History of Changes
Other Study ID Numbers: DR-PSE-306
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: October 12, 2011
Results First Posted: May 25, 2012
Last Update Posted: September 22, 2016
Last Verified: August 2016

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

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