Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)

• Status: Completed
• Trial end date: 2012-12-05
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Contraceptive Agents; Desogestrel; Ethinyl Estradiol; Etonogestrel; NuvaRing

Criteria

Inclusion Criteria:

• Women at risk of pregnancy and seeking contraception

Exclusion Criteria:

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