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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives|
- Bleeding patterns -Break through bleeding -Amount of bleeding -Days of bleeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- nausea and vomiting, breast tenderness, mood changes, elevation in blood pressure, stroke, blood clots, compliance and failure of contraception. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Ortho tricyclen™||
Drug: ortho tricyclen
brand name oral contraceptive
|Active Comparator: Trinessa™||
generic oral contraceptive
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.
|Contact: Frances Bechek, MD||248-992-0638||Frances.Becheck@beaumont.edu|
|Contact: Evie Russell, RN||248-898-5388||Evie.Russell@beaumont.edu|
|United States, Michigan|
|William Beaumont Hospital||Recruiting|
|Royal Oak, Michigan, United States, 48073|
|Contact: Frances Bechek, MD 248-992-0638 Frances.Bechek@beaumont.edu|
|Contact: Evie Russell, RN 248-898-5388 Evie.Russell@beaumont.edu|
|Principal Investigator:||Frances Bechek, MD||William Beaumont Hospitals|