Back to resultsA Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
Placebo tablet
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea focused on measuring cyclic pelvic pain, dysmenorrhea, oral contraceptives
Eligibility 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
Sites / Locations
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet
2
Arm Description
Outcomes
Primary Outcome Measures
Mean Change in Average Severity for Abdominal/Pelvic Pain
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
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
Number of Days Missed From School/Work or Other Activities
Analgesic Use
number of days analgesic (pain) medication was used over the 13 week treatment period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00196313
Brief Title
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duramed Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
cyclic pelvic pain, dysmenorrhea, oral contraceptives
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
Other Intervention Name(s)
Seasonique
Intervention Description
1 tablet daily by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
1 tablet daily by mouth
Primary Outcome Measure Information:
Title
Mean Change in Average Severity for Abdominal/Pelvic Pain
Description
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")
Time Frame
Baseline to end of 13-week treatment period
Secondary Outcome Measure Information:
Title
Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain
Description
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")
Time Frame
Baseline to end of Week 13
Title
Incidence of Menstrual Bleeding and /or Spotting
Time Frame
Baseline to end of Week 13
Title
Number of Days Missed From School/Work or Other Activities
Time Frame
13-week treatment period
Title
Analgesic Use
Description
number of days analgesic (pain) medication was used over the 13 week treatment period
Time Frame
13-week treatment period
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Duramed Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1088
Country
United States
Facility Name
Duramed Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Duramed Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Duramed Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duramed Investigational Site
City
Cincinatti
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Duramed Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Duramed Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Duramed Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Duramed Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Duramed Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Duramed Investigational Site
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Duramed Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Duramed Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
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