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Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

This study has been terminated.
(unale to recruit , progress report not filed by PI)
Sponsor:
Information provided by (Responsible Party):
John Uckele, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00775190
First received: October 17, 2008
Last updated: March 3, 2017
Last verified: March 2017
  Purpose

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 Intervention
Contraception
Drug: ortho tricyclen
Drug: Trinessa

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Basic Science
Official Title: Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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).

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

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


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

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

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

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

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

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


Enrollment: 12
Study Start Date: October 2008
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775190

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

Responsible Party: John Uckele, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00775190     History of Changes
Other Study ID Numbers: 2008-184
Study First Received: October 17, 2008
Results First Received: March 3, 2017
Last Updated: March 3, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by William Beaumont Hospitals:
birth control pills
oral contraceptives
brand name
generic
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
Moxifloxacin
Fluoroquinolones
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

ClinicalTrials.gov processed this record on April 21, 2017