Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
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.
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, amount of bleeding, and intermenstrual bleeding. Women will score these
 parameters using a survey with objective measures for days of bleeding, amount of flow, and
 days of breakthrough bleeding. As secondary outcomes, we will compare the side effect
 profiles of each in regards to nausea, vomiting, breast tenderness, menstrual cramps, mood
 changes, and thromboembolic events.

 Patients will record in their daily diary if one of the outcomes occurs or not. We will
 observe whether the events occur and the number of occurrences within the six month time
 period.
Inclusion Criteria:

 -  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 Criteria:

 -  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