Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
Information source: William Beaumont Hospitals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: ortho tricyclen (Drug); Trinessa (Drug)
Phase: N/A
Status: Terminated
Sponsored by: William Beaumont Hospitals Official(s) and/or principal investigator(s): Frances Bechek, MD, Principal Investigator, Affiliation: William Beaumont Hospitals
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.
Clinical Details
Official title: Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
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
Primary outcome: Bleeding patterns -Break through bleeding -Amount of bleeding -Days of bleeding
Secondary outcome: nausea and vomiting, breast tenderness, mood changes, elevation in blood pressure, stroke, blood clots, compliance and failure of contraception.
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
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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
Locations and Contacts
William Beaumont Hospital, Royal Oak, Michigan 48073, United States
Additional Information
Starting date: October 2008
Last updated: May 15, 2014
|