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

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ClinicalTrials.gov Identifier: NCT00196313
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : May 25, 2012
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Results First Submitted Date  ICMJE October 12, 2011
Results First Posted Date  ICMJE May 25, 2012
Last Update Posted Date September 22, 2016
Study Start Date  ICMJE May 2005
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
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")
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Change in patient reported severity of menstrual pain
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Change in total menstrual pain from weeks 1-13
  • Incidence of Menstrual Bleeding and /or Spotting
  • Number of Days Missed From School/Work or Other Activities
  • Analgesic Use
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dysmenorrhea
Intervention  ICMJE
  • Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
    1 tablet daily by mouth
    Other Name: Seasonique
  • Drug: Placebo tablet
    1 tablet daily by mouth
Study Arms  ICMJE
  • Experimental: 1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet
    Intervention: Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
  • Placebo Comparator: 2
    Intervention: Drug: Placebo tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2012)
95
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
40
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00196313
Other Study ID Numbers  ICMJE DR-PSE-306
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Duramed Research )
Study Sponsor  ICMJE Duramed Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Teva Pharmaceutical Industries
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP