Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00775190
Recruitment Status : Terminated (unale to recruit , progress report not filed by PI)
First Posted : October 20, 2008
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Information provided by (Responsible Party):
John Uckele, William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: ortho tricyclen Drug: Trinessa Not Applicable

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  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
Study Start Date : October 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Amount of Bleeding [ Time Frame: 6 Months ]
    Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).

  2. Incidence of Breakthrough Bleeding [ Time Frame: 6 months ]
    Any breakthrough bleeding during reporting period.

  3. Days of Bleeding [ Time Frame: 6 months ]
    Number of days with bleeding during each menstrual period.

Secondary Outcome Measures :
  1. Side Effects (Nausea) [ Time Frame: 6 months ]
    Number of days of nausea

  2. Side Effects (Vomiting) [ Time Frame: 6 Months ]
    Number of episodes of vomitting

  3. Side Effects (Breast Tenderness) [ Time Frame: 6 Months ]
    Incidence of breast tenderness during the study time frame

  4. Side Effects (Mood Changes) [ Time Frame: 6 months ]
    Self reported changes in mood during each month over the time frame.

  5. Side Effects (Menstrual Cramps) [ Time Frame: 6 months ]
    Intensity of menstrual cramps reported on a 4 point Likert scale.

  6. Side Effects (Incidence of Thromboembolic Events) [ Time Frame: 6 months ]
    Occurrence of any thromboembolic events during the study time frame.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00775190

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Principal Investigator: Frances Bechek, MD William Beaumont Hospitals

Responsible Party: John Uckele, Principal Investigator, William Beaumont Hospitals Identifier: NCT00775190     History of Changes
Other Study ID Numbers: 2008-184
First Posted: October 20, 2008    Key Record Dates
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John Uckele, William Beaumont Hospitals:
birth control pills
oral contraceptives
brand name
side effects
oral contraceptive side effects
dysfunctional uterine bleeding
pre-menstrual symptoms

Additional relevant MeSH terms:
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors