Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

Contraception Clinical Trial

Official title:

Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00775190
• Other study ID #: 2008-184
• Status: Terminated
• Phase: N/A
• First received: October 17, 2008
• Last updated: May 15, 2014
• Start date: October 2008
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• ortho tricyclen
brand name oral contraceptive
• Trinessa
generic oral contraceptive

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding patterns -Break through bleeding -Amount of bleeding -Days of bleeding		6 months	No
Secondary	nausea and vomiting, breast tenderness, mood changes, elevation in blood pressure, stroke, blood clots, compliance and failure of contraception.		6 months	No