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

NCT ID: NCT01490190

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-26
• Study Completion Date: 2012-12-05

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.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NuvaRing

Group Type: EXPERIMENTAL

Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)

Intervention Type: DRUG

Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.

Interventions

Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)

Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.

Intervention Type: DRUG

Other Intervention Names

NuvaRing; SCH 900702

Eligibility Criteria

Inclusion Criteria

• Women at risk of pregnancy and seeking contraception

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CTRI/2011/11/002098

Identifier Type: REGISTRY

Identifier Source: secondary_id

P07733

Identifier Type: -

Identifier Source: org_study_id