Trial Outcomes & Findings for Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives (NCT NCT00775190)
NCT ID: NCT00775190
Last Updated: 2017-04-17
Results Overview
Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).
TERMINATED
NA
12 participants
6 Months
2017-04-17
Participant Flow
Participant milestones
| Measure |
Ortho Tricyclen™
ortho tricyclen: brand name oral contraceptive
|
Trinessa™
Trinessa: generic oral contraceptive
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Ortho Tricyclen™
ortho tricyclen: brand name oral contraceptive
|
Trinessa™
Trinessa: generic oral contraceptive
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
Baseline characteristics by cohort
| Measure |
Ortho Tricyclen™
n=7 Participants
ortho tricyclen: brand name oral contraceptive
|
Trinessa™
n=5 Participants
Trinessa: generic oral contraceptive
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
24 years
n=99 Participants
|
24 years
n=107 Participants
|
24 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
5 participants
n=107 Participants
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Study Terminated with no data analysis.
Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: Study Terminated with no data analysis
Any breakthrough bleeding during reporting period.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: Study Terminated with no data analysis
Number of days with bleeding during each menstrual period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Study Terminated with no data analysis
Number of days of nausea
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Study Terminated with no data analysis
Number of episodes of vomitting
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Study Terminated with no data analysis
Incidence of breast tenderness during the study time frame
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Study Terminated with no data analysis
Self reported changes in mood during each month over the time frame.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Study Terminated with no data analysis
Intensity of menstrual cramps reported on a 4 point Likert scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Study Terminated with no data analysis
Occurrence of any thromboembolic events during the study time frame.
Outcome measures
Outcome data not reported
Adverse Events
Ortho Tricyclen™
Trinessa™
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place