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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives|
- Amount of Bleeding [ Time Frame: 6 Months ]Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).
- Incidence of Breakthrough Bleeding [ Time Frame: 6 months ]Any breakthrough bleeding during reporting period.
- Days of Bleeding [ Time Frame: 6 months ]Number of days with bleeding during each menstrual period.
- Side Effects (Nausea) [ Time Frame: 6 months ]Number of days of nausea
- Side Effects (Vomiting) [ Time Frame: 6 Months ]Number of episodes of vomitting
- Side Effects (Breast Tenderness) [ Time Frame: 6 Months ]Incidence of breast tenderness during the study time frame
- Side Effects (Mood Changes) [ Time Frame: 6 months ]Self reported changes in mood during each month over the time frame.
- Side Effects (Menstrual Cramps) [ Time Frame: 6 months ]Intensity of menstrual cramps reported on a 4 point Likert scale.
- Side Effects (Incidence of Thromboembolic Events) [ Time Frame: 6 months ]Occurrence of any thromboembolic events during the study time frame.
|Study Start Date:||October 2008|
|Study Completion Date:||November 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Ortho tricyclen™
Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily
Drug: ortho tricyclen
brand name oral contraceptive
Active Comparator: Trinessa™
Participant Randomized to Trinessa 1 tablet by mouth Daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775190
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Frances Bechek, MD||William Beaumont Hospitals|