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

Organon

Status and phase

Completed

Phase 4

Conditions

Contraception

Treatments

Drug: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01490190

CTRI/2011/11/002098 (Registry Identifier)

P07733

Details and patient eligibility

About

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.

Enrollment

252 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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