A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Phase 3
Completed
- Conditions
- Dysmenorrhea
- Interventions
- Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tabletsDrug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo
- Registration Number
- NCT00196365
- Lead Sponsor
- Duramed Research
- 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 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 97
Inclusion Criteria
- Moderate to severe menstrual-related pain
- Regular spontaneous menstrual cycles
Exclusion Criteria
- Any contraindication to the use of oral contraceptives
- Treatment with an oral contraceptive in the last 3 months
- Previous treatment failure with an extended oral contraceptive regimen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets - 2 levonorgestrel/EE 0.15/0.03 mg tablets and placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in the clinical assessment of dysmenorrhea Baseline to Week 4,8,12,24, and 26 or early discontinuation
- Secondary Outcome Measures
Name Time Method Analgesic use Duration of study Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms) Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation Incidence of menstrual bleeding and/or spotting Duration of study
Trial Locations
- Locations (1)
Duramed Investigational Site
🇺🇸Tacoma, Washington, United States