PROMES: PROspective, Non-Interventional, Observational, Longitudinal Study to Describe the Safety Profile of MESIGYNA® (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) as a Contraceptive Method for Women in Reproductive Age at the Outpatient Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Frequency of Adverse Events and Serious Adverse Events
研究概览
简要总结
Clinical study in which researchers want to learn more about the safety profile of MESIGYNA used as a medication in routine clinical practice to prevent pregnancy. In order to find this out researchers will collect historic and treatment related data during initial visit and follow-up visits of adult women in reproductive age in the Peruvian population at the outpatient clinic. Mesigyna is a combined injectable birth control medication (norethindrone ethanate (50 mg) and estradiol valerate (5 mg)) for women given monthly.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients,18 to 45 years old with a Mesigyna prescription
- •Women for whom the decision to initiate contraception with Mesigyna was made as per investigator's routine practice
- •Signed Informed Consent
排除标准
- •Women participating in an investigational program with interventions outside of routine clinical practice
- •Hypersensitivity to norethisterone enantate or estradiol valerate
研究组 & 干预措施
BAY98-7040
Female adult patients of reproductive age, who want to use a contraceptive method, will be enrolled after the investigator has made the decision for treatment with Mesigyna.
Investigators should prescribe Mesigyna for medically approved indications as per the label of the medicine locally approved.
干预措施: Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040) (Drug)
结局指标
主要结局
Frequency of Adverse Events and Serious Adverse Events
时间窗: Up to 6 months
次要结局
- Number of injections(Up to 6 months)
- Frequency of injections(Up to 6 months)
- The number of injections(Up to 6 months)
- Comorbidities associated to greater incidence of AE and SAE(Up to 6 months)