Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
| Status: | Completed |
|---|---|
| Conditions: | Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 5/5/2014 |
| Start Date: | October 2008 |
| End Date: | April 2014 |
| Contact: | Frances Bechek, MD |
| Email: | Frances.Becheck@beaumont.edu |
| Phone: | 248-992-0638 |
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.
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.
(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 thromboembolism
- mental disabilities
- desire to become pregnant in the next six months
We found this trial at
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William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
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