Expired Study
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Royal Oak, Michigan 48073


Purpose:

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 summary:

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.


Criteria:

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


NCT ID:

NCT00775190


Primary Contact:

Principal Investigator
Frances Bechek, MD
William Beaumont Hospitals


Backup Contact:

N/A


Location Contact:

Royal Oak, Michigan 48073
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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