Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

Conditions
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Contraception

Intervention / Treatment
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* Drug: ortho tricyclen
* Drug: Trinessa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ortho tricyclen™<br>Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily | Drug: ortho tricyclen<br>* brand name oral contraceptive<br>|
| Active Comparator: Trinessa™<br>Participant Randomized to Trinessa 1 tablet by mouth Daily | Drug: Trinessa<br>* generic oral contraceptive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Bleeding | Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy). | 6 Months | 
| Incidence of Breakthrough Bleeding | Any breakthrough bleeding during reporting period. | 6 months | 
| Days of Bleeding | Number of days with bleeding during each menstrual period. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects (Nausea) | Number of days of nausea | 6 months | 
| Side Effects (Vomiting) | Number of episodes of vomitting | 6 Months | 
| Side Effects (Breast Tenderness) | Incidence of breast tenderness during the study time frame | 6 Months | 
| Side Effects (Mood Changes) | Self reported changes in mood during each month over the time frame. | 6 months | 
| Side Effects (Menstrual Cramps) | Intensity of menstrual cramps reported on a 4 point Likert scale. | 6 months | 
| Side Effects (Incidence of Thromboembolic Events) | Occurrence of any thromboembolic events during the study time frame. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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birth control pills, oral contraceptives, brand name, generic, side effects, oral contraceptive side effects, dysfunctional uterine bleeding, pre-menstrual symptoms