Clinical trial NCT00775190: Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
Official title: Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Contraception
Keywords: birth control pills
oral contraceptives
brand name
generic
side effects
oral contraceptive side effects
dysfunctional uterine bleeding
pre-menstrual symptoms
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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 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

Primary outcomes:
measure: Amount of Bleeding
timeFrame: 6 Months
measure: Incidence of Breakthrough Bleeding
timeFrame: 6 months
measure: Days of Bleeding
timeFrame: 6 months
Secondary outcomes:
measure: Side Effects (Nausea)
timeFrame: 6 months
measure: Side Effects (Vomiting)
timeFrame: 6 Months
measure: Side Effects (Breast Tenderness)
timeFrame: 6 Months
measure: Side Effects (Mood Changes)
timeFrame: 6 months
measure: Side Effects (Menstrual Cramps)
timeFrame: 6 months
measure: Side Effects (Incidence of Thromboembolic Events)
timeFrame: 6 months
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Frances Bechek, MD
role: PRINCIPAL_INVESTIGATOR
References: