DRKS00014982已完成不适用
on-interventional retrospective study to evaluate the menstrual cycle profiles and quality of life of women after the use of the new vaginal ring GinoRing® delivering 0.120mg etonogestrel and 0.015mg ethinylestradiol per day - Evol Study
Exeltis Germany GmbH0 个研究点目标入组 103 人开始时间: 2018年8月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •1. Female patients, age = 18 and = 45 years
- •2. Usage of the GinoRing® as contraceptive method for at least 6 months
- •3. Signed informed consent
排除标准
- •1. Current BMI > 30 kg/m2
- •2. Patients with severe acute or chronic diseases (e.g. pancreatitis, hypertriglyceridemia, liver disease, benign or malign liver tumor, malign sex-hormone dependent diseases of genitals or breasts)
- •3. Migraine
- •4. Intake of herbal medicines which induce microsomal enzymes, especially cytochrome-P450-enzyme, e.g. Phenytoin, Phenobarbital, Primidon, Bosentan, Carbamazepin, Rifampicin, Topiramat, Felbamat, Griseofulvin, a few HIV protease inhibitors (e.g. Ritonavir), and non-nucleosidic Reverse-Transcriptase-Inhibitors (e.g. Efavirenz) as well as preparations of Aaron´s beard.
- •5. History of cardiovascular events
- •6. Advanced hypertension or diabetes
- •7. Presence or known risk of venous or arterial thromboembolism
- •8. Known hypersensitivity to components of GinoRing®
- •9. Undiagnosed abnormal vaginal bleeding
- •10. Use of drugs containing Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir during and two weeks before start of the study
- •11. Patients using intrauterine devices (IUD) or intrauterine systems (IUS)
- •12. Pregnancy and breastfeeding during the whole study duration
- •13. Patients who are postmenopausal
- •14. Smoker
- •15. Participation in any other trial 30 days before starting to use the GinoRing®
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