Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

NCT ID: NCT00775190

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2013-11-30

Brief Summary

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

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Ortho tricyclen™

Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily

Group Type: ACTIVE_COMPARATOR

ortho tricyclen

Intervention Type: DRUG

brand name oral contraceptive

Trinessa™

Participant Randomized to Trinessa 1 tablet by mouth Daily

Group Type: ACTIVE_COMPARATOR

Trinessa

Intervention Type: DRUG

generic oral contraceptive

Interventions

ortho tricyclen

brand name oral contraceptive

Intervention Type: DRUG

Trinessa

generic oral contraceptive

Intervention Type: DRUG

Eligibility 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 Blood clots (thromboembolism)
• mental disabilities
• desire to become pregnant in the next six months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

John Uckele

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frances Bechek, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

William Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2008-184

Identifier Type: -

Identifier Source: org_study_id