Contraceptive vaginal ring releasing etonogestrel and ethinylestradiol (NuvaRing): Cycle control, acceptability and tolerability study in Indian women

Merck Sharp and Dohme0 个研究点目标入组 250 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Exclusion criteria based on approved prescribing information in India:
•Presence or history of venous thrombosis, with or without pulmonary embolism.
•Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or
•transient ischemic attack).
•Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
•History of migraine with focal neurological symptoms.
•Diabetes mellitus with vascular involvement.
•The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (at the discretion of the doctors)
•Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
•Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
•Presence or history of liver tumors (benign or malignant).
•Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced.
•Undiagnosed vaginal bleeding.
•Known or suspected pregnancy.
•Hypersensitivity to the active substances or to any of the excipients of NuvaRing.
•Women who are breast feeding

发起方

Merck Sharp and Dohme