NCT02574715已完成不适用
A Cross-sectional, Observational Study to Assess Quality of Life and Satisfaction of Young Women (Aged 18-29) Following 6 (±1) Months Using Jaydess® as Their Contraceptive Method - The JULIA Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,039
- 主要终点
- Quality of life as determined using the SEC-QoL scale
研究概览
简要总结
This is a cross-sectional, multicenter observational study to assess quality of life in young Spanish women (aged 18 to 29) who use Jaydess® as their contraceptive method. The study will be conducted in standard clinical practice conditions at the private gynecology clinics and during a single study visit.
Approximately 1,200 women who have been using the intrauterine delivery system (IUS) Jaydess® as their contraceptive method of choice for 6 (±1) months 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 have been using Jaydess as their contraceptive method for 6 (±1) months.
- •Women who have no comprehension, reading or writing challenges.
- •Women who have given informed consent in writing.
排除标准
- •Contraindication to the use of Jaydess.
- •Prescription of Jaydess® for non-contraceptive medical reasons.
- •Women who are considered to be unsuitable to take part in the study by the investigator (e.g., poor understanding of the study characteristics, uncooperative, etc.).
- •Women who are currently taking part in any clinical trial.
研究组 & 干预措施
Levonorgestrel (Jaydess, BAY86-5028)
women aged 18 to 29 years following 6 (±1) months of Jaydess® use as their contraceptive method.
干预措施: Levonorgestrel (Jaydess, BAY86-5028) (Drug)
结局指标
主要结局
Quality of life as determined using the SEC-QoL scale
时间窗: At the single visit
SEC-QoL (Spanish Contraception Society Quality of Life Questionnaire) is to assess the impact of contraceptive methods on health-related quality of life in women.
次要结局
- Place of Birth(At the single visit)
- Maternity status (has children or plans to have children)(At the single visit)
- History of type of contraceptive use(At the single visit)
- Age (years)(At the single visit)
- History of duration of contraceptive use(At the single visit)
- Global assessment of the insertion by means of a structured interview for pain questions (any, slight, moderate, severe)(At the single visit)
- Global assessment of the insertion (acceptable without discomfort, with a few of minimal discomfort or with an enormous discomfort and unacceptable)(At the single visit)
- Place of residence (province, town, city or rural area)(At the single visit)
- Educational level (primary, secondary or higher education)(At the single visit)
- Prescription of Jaydess (date)(At the single visit)
- Benefits perceived on ease and comfort of use by means of a structured interview (Yes, No)(At the single visit)
- Marital Status(At the single visit)
- Frequency attending this physician's clinic for family planning purposes(At the single visit)
- Employment (working outside the home, working from home, unemployed, student)(At the single visit)
- Global assessment of the insertion by means of a structured interview for times questions(At the single visit)
- Global satisfaction with Jaydess, using a structured questionaire(At the single visit)
- Bleeding pattern features, using a questionnaire to compare current bleeding versus bleeding before the insertion of Jaydess as recalled(At the single visit)
研究者
相似试验
已完成
不适用
An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With RituximabRheumatoid ArthritisNCT02507752Hoffmann-La Roche94
已完成
不适用
An Observational Study of Epoetin Beta [Neorecormon] to Evaluate the Quality of Life in Patients on Dialysis With Chronic Renal AnemiaAnemiaNCT01105494Hoffmann-La Roche6,000
已完成
不适用
An Observational Study to Assess the Quality of Life of the Patients With Multiple Sclerosis and Their CaregiversMultiple SclerosisNCT01075737Merck KGaA, Darmstadt, Germany141
已完成
不适用
An Observational Study to Evaluate Quality of Life (QoL) and Influence of Cognitive Status on QoL in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) During 2 Years Treatment With Rebif New Formulation (RNF)Multiple Sclerosis, Relapsing-RemittingNCT01110993Merck KGaA, Darmstadt, Germany65
已完成
不适用
Prospective cohort study to assess quality of life, surgical outcomes, and perioperative complications following implant-based breast reconstructioC50.9Breast, unspecifiedDRKS00034493Rotkreuzklinikum München gGmbH - Hauptabteilung Gynäkologie308