drugset / Trial / NCT00775190
Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ortho Tri-Cyclen | Unknown | — | Oral |
| Comparator | Trinessa | Unknown | — | Oral |
Indications
No indication recorded.