Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00775190

Enrollment

Registered

2008-10-20

Start date

2008-10-31

Completion date

2013-11-30

Last updated

2017-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

birth control pills, oral contraceptives, brand name, generic, side effects, oral contraceptive side effects, dysfunctional uterine bleeding, pre-menstrual symptoms

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.

Interventions

DRUGortho tricyclen

brand name oral contraceptive

DRUGTrinessa

generic oral contraceptive

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Amount of Bleeding	6 Months	Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).
Incidence of Breakthrough Bleeding	6 months	Any breakthrough bleeding during reporting period.
Days of Bleeding	6 months	Number of days with bleeding during each menstrual period.

Secondary

Measure	Time frame	Description
Side Effects (Mood Changes)	6 months	Self reported changes in mood during each month over the time frame.
Side Effects (Nausea)	6 months	Number of days of nausea
Side Effects (Incidence of Thromboembolic Events)	6 months	Occurrence of any thromboembolic events during the study time frame.
Side Effects (Menstrual Cramps)	6 months	Intensity of menstrual cramps reported on a 4 point Likert scale.
Side Effects (Vomiting)	6 Months	Number of episodes of vomitting
Side Effects (Breast Tenderness)	6 Months	Incidence of breast tenderness during the study time frame

Countries

United States

Participant flow

Participants by arm

Arm	Count
Ortho Tricyclen™ ortho tricyclen: brand name oral contraceptive	7
Trinessa™ Trinessa: generic oral contraceptive	5
Total	12

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	3
Overall Study	Protocol Violation	1	0
Overall Study	Withdrawal by Subject	1	2

Baseline characteristics

Characteristic	Trinessa™	Ortho Tricyclen™	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	5 Participants	7 Participants	12 Participants
Age, Continuous	24 years	24 years	24 years
Region of Enrollment United States	5 participants	7 participants	12 participants
Sex: Female, Male Female	5 Participants	7 Participants	12 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 7	0 / 5
other Total, other adverse events	0 / 7	0 / 5
serious Total, serious adverse events	0 / 7	0 / 5

Outcome results

Primary

Amount of Bleeding

Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).

Time frame: 6 Months

Population: Study Terminated with no data analysis.

Primary