drugset / Trial / NCT00775190

Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

NCT00775190

Terminated 12 enrolled Corewell Health East
RandomizedParallel-groupQuadruple-blindBasic science

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 Trinessa oral contraceptives and will be asked to keep a daily dairy of any symptoms or bleeding experienced. Once a month, participants will be asked to complete a survey. The objective is to compare generic oral contraceptives (OCPs) and brand name OCPs with respect to side effect profiles including bleeding patterns, mood changes, nausea and vomiting, frequency of menstrual cramps, breast tenderness, elevation in blood pressure, stroke, blood clots and patient compliance.

Timeline

Start
2008-10
Primary completion
2013-10
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ortho Tri-Cyclen Unknown Oral
Comparator Trinessa Unknown Oral

Indications

No indication recorded.