Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of Breakthrough Bleeding
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ortho tricyclen™
Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily
干预措施: ortho tricyclen (Drug)
Trinessa™
Participant Randomized to Trinessa 1 tablet by mouth Daily
干预措施: Trinessa (Drug)
结局指标
主要结局
Incidence of Breakthrough Bleeding
时间窗: 6 months
Any breakthrough bleeding during reporting period.
Amount of Bleeding
时间窗: 6 Months
Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).
Days of Bleeding
时间窗: 6 months
Number of days with bleeding during each menstrual period.
次要结局
- Side Effects (Breast Tenderness)(6 Months)
- Side Effects (Incidence of Thromboembolic Events)(6 months)
- Side Effects (Menstrual Cramps)(6 months)
- Side Effects (Nausea)(6 months)
- Side Effects (Vomiting)(6 Months)
- Side Effects (Mood Changes)(6 months)
研究者
John Uckele
Principal Investigator
William Beaumont Hospitals