Status:
COMPLETED
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Lead Sponsor:
Duramed Research
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
Up to 17 years
Phase:
PHASE2
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 inter...
Eligibility Criteria
Inclusion
- Sexually naïve and agree to abstain from sex during the study
- Moderate to severe menstrual-related pelvic pain
- Regular spontaneous menstrual cycles
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00196313
Start Date
May 1 2005
End Date
October 1 2008
Last Update
September 22 2016
Active Locations (13)
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1
Duramed Investigational Site
Denver, Colorado, United States, 80218-1088
2
Duramed Investigational Site
Decatur, Georgia, United States, 30034
3
Duramed Investigational Site
Louisville, Kentucky, United States, 40202
4
Duramed Investigational Site
St Louis, Missouri, United States, 63110