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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet<br> | Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets<br>* 1 tablet daily by mouth<br>* Other names: Seasonique;|
| Placebo Comparator: 2<br> | Drug: Placebo tablet<br>* 1 tablet daily by mouth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline to end of 13-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline to end of Week 13 | 
| Incidence of Menstrual Bleeding and /or Spotting |  | Baseline to end of Week 13 | 
| Number of Days Missed From School/Work or Other Activities |  | 13-week treatment period | 
| Analgesic Use | number of days analgesic (pain) medication was used over the 13 week treatment period | 13-week treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cyclic pelvic pain, dysmenorrhea, oral contraceptives