Status:
TERMINATED
Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
Lead Sponsor:
Corewell Health East
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
This is a randomized control trial of Ortho tricyclen versus Trinessa (generic equivalent) to determine if they have similar effects. Women will be randomized to receive either Ortho tricyclen or Trin...
Detailed Description
This is a double blind randomized controlled trial of Ortho tricyclen™ vs. Trinessa™ (generic equivalent) to determine if they have similar effects on bleeding patterns, namely days of menstrual flow,...
Eligibility Criteria
Inclusion
- nonsmoker
- not pregnant
- not planning to become pregnant in the next 6 months
- not taking hormonal birth control for at least 3 months previous to entering the study
- no history of fibroids
- no history of ovarian cysts
- no history of dysfunctional uterine bleeding
Exclusion
- pregnant
- under the age of 18
- over the age of 35
- history of irregular uterine bleeding
- history of ovarian cysts
- history of fibroids
- history of migraines with aura
- history of liver disease
- family or personal history of Blood clots (thromboembolism)
- mental disabilities
- desire to become pregnant in the next six months
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00775190
Start Date
October 1 2008
End Date
November 1 2013
Last Update
April 17 2017
Active Locations (1)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073