Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
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
Outcome
Outcome not reported
Stopped (Enrollment): “unale to recruit , progress report not filed by PI”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ortho Tri-Cyclen | Unknown | — | Oral |
| Comparator | Trinessa | Unknown | — | Oral |
Indications
No indication recorded.