Status:
COMPLETED
Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)
Lead Sponsor:
Organon and Co
Conditions:
Contraception
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.
Eligibility Criteria
Inclusion
- Women at risk of pregnancy and seeking contraception
Exclusion
- 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
Key Trial Info
Start Date :
December 26 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2012
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT01490190
Start Date
December 26 2011
End Date
December 5 2012
Last Update
May 24 2024
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