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Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

This study is currently recruiting participants.
Verified August 2012 by William Beaumont Hospitals
Sponsor:
Information provided by (Responsible Party):
Frances Bechek, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00775190
First received: October 17, 2008
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Bleeding patterns -Break through bleeding -Amount of bleeding -Days of bleeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • nausea and vomiting, breast tenderness, mood changes, elevation in blood pressure, stroke, blood clots, compliance and failure of contraception. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ortho tricyclen™ Drug: ortho tricyclen
brand name oral contraceptive
Active Comparator: Trinessa™ 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
Genders 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 thromboembolism
  • mental disabilities
  • desire to become pregnant in the next six months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775190

Contacts
Contact: Frances Bechek, MD 248-992-0638 Frances.Becheck@beaumont.edu
Contact: Evie Russell, RN 248-898-5388 Evie.Russell@beaumont.edu

Locations
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Frances Bechek, MD     248-992-0638     Frances.Bechek@beaumont.edu    
Contact: Evie Russell, RN     248-898-5388     Evie.Russell@beaumont.edu    
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Frances Bechek, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Frances Bechek, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00775190     History of Changes
Other Study ID Numbers: 2008-184
Study First Received: October 17, 2008
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

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
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Anti-Infective Agents
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on June 18, 2013