Side Effect Profiles of Brand Name vs.Generic Oral Contraceptives - Full Text View

Sponsor:	William Beaumont Hospitals
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00775190

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:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Bio-equivalence Study
Official Title:	Side Effect Profiles of Brand Name vs.Generic Oral Contraceptives

Resource links provided by NLM:

MedlinePlus related topics: Birth Control Nausea and Vomiting

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:	May 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ortho tricyclen™: Active Comparator	Drug: ortho tricyclen brand name oral contraceptive
Trinessa™: Active Comparator	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: Kami Palmer, MD	517-282-0774	Kami.palmer@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: Kami Palmer, MD 248-992-0365 Kami.palmer@beaumont.edu
Contact: Evie Russell, RN 248-898-5388 Evie.Russell@beaumont.edu

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

Principal Investigator:

Kami Palmer, MD

William Beaumont Hospitals

More Information

No publications provided

Responsible Party:	William Beaumont Hospital ( Kami Palmer, M.D. )
Study ID Numbers:	2008-184
Study First Received:	October 17, 2008
Last Updated:	December 9, 2009
ClinicalTrials.gov Identifier:	NCT00775190 History of Changes
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
Therapeutic Uses
Physiological Effects of Drugs
Contraceptives, Oral

Contraceptive Agents, Female
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010