A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 886
- 主要终点
- Reason for choosing Jaydess as intrauterine device (IUD)
研究概览
简要总结
A cross-sectional, observational multicenter study to assess the reasons for choosing the 3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years. The study will be conducted in standard clinical practice conditions at public and private gynecology clinics and during a single study visit.
Approximately 1,000 women aged 18 to 29 years who have freely chosen the 3 year hormonal IUD as their contraceptive method will be included in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 29 years.
- •Women who decided to initiate treatment with a 3-year hormonal IUD for contraception after being adequately counseled and informed of all contraceptive options by their physician during a routine clinical visit, prior to the study visit (insertion visit).
- •Women capable of reading and writing.
- •Women who signed informed consent.
排除标准
- •Women currently participating in an interventional clinical trial.
- •Prescription of the 3-year hormonal IUD for non-contraceptive medical reasons.
研究组 & 干预措施
BAY86-5028
Women aged 18 to 29 years that use Jaydess for contraception
干预措施: Levonorgestrel (Jaydess, Skyla, BAY86-5028) (Drug)
结局指标
主要结局
Reason for choosing Jaydess as intrauterine device (IUD)
时间窗: day 1
The participants select the reason out of a given list of 15 possible reasons
Reason for switching to Jaydess if used another type of intrauterine device before
时间窗: day 1
The participants select the reason out of a given list of 10 possible reasons
Knowledge of Jaydess or other IUDs prior to the visit
时间窗: day 1
The participants select the reason out of a given list of 3 possible reasons
Is the first intrauterine device prescribed?
时间窗: day 1
Possible reasons: Yes or No
Person who encouraged the use of jaydess?
时间窗: day 1
The participants select the answer out of a given list of 5 possible people
次要结局
- Number of children(day 1)
- Income level(day 1)
- Do you have children? (Y/N)(day 1)
- Reason for not using Jaydess or other intrauterine delivery system (IUD) before(day 1)
- Uterine length as measured by ultrasonography(day 1)
- Presence of dysmenorrhea (Y/N)(day 1)
- Current contraception method(day 1)
- Date of birth(day 1)
- Marital status(day 1)
- Place of birth(day 1)
- Place of residence(day 1)
- Educational level(day 1)
- Employment(day 1)
- Has she had some birth vaginally? (Y/N)(day 1)
- Date of last birth(day 1)
- Do you plan to have (more) children? (Yes/No/Unknown)(day 1)
- Frequency of menstrual bleeding(day 1)
- Absence of menstrual bleeding(day 1)
- When she plans to have (more) children(day 1)
- Regularity of menstrual bleeding(day 1)
- Quantity of menstrual bleeding(day 1)
- Duration of menstrual bleeding(day 1)
- Questionnaire concerning the physicians' characteristics(day 1)