Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

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 Overview

• Status: Terminated
• Conditions: Contraception
• Intervention / Treatment: Drug: ortho tricyclen; Drug: Trinessa

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ortho tricyclen™; Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily	Drug: ortho tricyclen; brand name oral contraceptive
ACTIVE_COMPARATOR: Trinessa™; Participant Randomized to Trinessa 1 tablet by mouth Daily	Drug: Trinessa; generic oral contraceptive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Bleeding	Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).	6 Months
Incidence of Breakthrough Bleeding	Any breakthrough bleeding during reporting period.	6 months
Days of Bleeding	Number of days with bleeding during each menstrual period.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side Effects (Nausea)	Number of days of nausea	6 months
Side Effects (Vomiting)	Number of episodes of vomitting	6 Months
Side Effects (Breast Tenderness)	Incidence of breast tenderness during the study time frame	6 Months
Side Effects (Mood Changes)	Self reported changes in mood during each month over the time frame.	6 months
Side Effects (Menstrual Cramps)	Intensity of menstrual cramps reported on a 4 point Likert scale.	6 months
Side Effects (Incidence of Thromboembolic Events)	Occurrence of any thromboembolic events during the study time frame.	6 months

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Frances Bechek, MD, William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: October 17, 2008
• First Submitted That Met QC Criteria: October 17, 2008
• First Posted (ESTIMATE): October 20, 2008

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2017
• Last Update Submitted That Met QC Criteria: March 3, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: oral contraceptives; side effects; generic; birth control pills; dysfunctional uterine bleeding; brand name; oral contraceptive side effects; pre-menstrual symptoms
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: 2008-184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO