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unale to recruit , progress report not filed by PI
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ortho tricyclen™ | Active Comparator | Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily |
|
| Trinessa™ | Active Comparator | Participant Randomized to Trinessa 1 tablet by mouth Daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ortho tricyclen | Drug | brand name oral contraceptive |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Bleeding | Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy). | 6 Months |
| Incidence of Breakthrough Bleeding | Any breakthrough bleeding during reporting period. | 6 months |
| Days of Bleeding | Number of days with bleeding during each menstrual period. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects (Nausea) | Number of days of nausea | 6 months |
| Side Effects (Vomiting) | Number of episodes of vomitting | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances Bechek, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ortho Tricyclen™ | ortho tricyclen: brand name oral contraceptive |
| FG001 | Trinessa™ | Trinessa: generic oral contraceptive |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ortho Tricyclen™ | ortho tricyclen: brand name oral contraceptive |
| BG001 | Trinessa™ | Trinessa: generic oral contraceptive |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amount of Bleeding | Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy). | Study Terminated with no data analysis. | Posted | 6 Months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ortho Tricyclen™ | ortho tricyclen: brand name oral contraceptive | 0 |
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Early Study termination. No data analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evie Russell, RN | Beaumont Health System | 248-898-5388 | Evie.Russell@beaumont.org |
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Trinessa |
| Drug |
generic oral contraceptive |
|
| Side Effects (Breast Tenderness) | Incidence of breast tenderness during the study time frame | 6 Months |
| Side Effects (Mood Changes) | Self reported changes in mood during each month over the time frame. | 6 months |
| Side Effects (Menstrual Cramps) | Intensity of menstrual cramps reported on a 4 point Likert scale. | 6 months |
| Side Effects (Incidence of Thromboembolic Events) | Occurrence of any thromboembolic events during the study time frame. | 6 months |
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | target population females ages 18-65 | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Beaumont Health System patient population | Number | participants |
|
| Participants |
|
| Primary | Incidence of Breakthrough Bleeding | Any breakthrough bleeding during reporting period. | Study Terminated with no data analysis | Posted | 6 months |
|
|
| Primary | Days of Bleeding | Number of days with bleeding during each menstrual period. | Study Terminated with no data analysis | Posted | 6 months |
|
|
| Secondary | Side Effects (Nausea) | Number of days of nausea | Study Terminated with no data analysis | Posted | 6 months |
|
|
| Secondary | Side Effects (Vomiting) | Number of episodes of vomitting | Study Terminated with no data analysis | Posted | 6 Months |
|
|
| Secondary | Side Effects (Breast Tenderness) | Incidence of breast tenderness during the study time frame | Study Terminated with no data analysis | Posted | 6 Months |
|
|
| Secondary | Side Effects (Mood Changes) | Self reported changes in mood during each month over the time frame. | Study Terminated with no data analysis | Posted | 6 months |
|
|
| Secondary | Side Effects (Menstrual Cramps) | Intensity of menstrual cramps reported on a 4 point Likert scale. | Study Terminated with no data analysis | Posted | 6 months |
|
|
| Secondary | Side Effects (Incidence of Thromboembolic Events) | Occurrence of any thromboembolic events during the study time frame. | Study Terminated with no data analysis | Posted | 6 months |
|
|
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Trinessa™ | Trinessa: generic oral contraceptive | 0 | 5 | 0 | 5 | 0 | 5 |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |