Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

Stopped early · Not applicable

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT00775190

Run by

Corewell Health East

People needed

12

Starts

2008-10-01

Expected to finish

2013-11-01

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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