Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

William Beaumont Hospitals

Status: Terminated

Conditions: Contraception

Treatments: Drug: ortho tricyclen; Drug: Trinessa

Study type: Interventional

Funder types: Other

Identifiers

NCT00775190

2008-184

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups

Ortho tricyclen™

Active Comparator group

Description:

Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily

Treatment:

Drug: ortho tricyclen

Trinessa™

Active Comparator group

Description:

Participant Randomized to Trinessa 1 tablet by mouth Daily

Treatment:

Drug: Trinessa