Contraceptive vaginal ring releasing etonogestrel and ethinylestradiol (NuvaRing): Study of the use of a contraceptive vaginal ring (NuvaRing) in normal daily practice in Indian wome

Phase 4

Completed

• Registration Number: CTRI/2011/11/002110
• Lead Sponsor: Merck Sharp and Dohme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

There is no upper age limit specified for this study

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Participants with regular menstrual cycles <br/ ><br>-Participants with breakthrough bleeding/spotting <br/ ><br>-Average number of bleeding days, pads used per day and bleeding/spotting days <br/ ><br>-Assessment of ease of insertion and removal <br/ ><br>-Frequency of feeling ring at any time or during intercourse <br/ ><br>-Frequency of partner feeling ring during intercourse or of objection to ring use <br/ ><br>-Participants overall satisfaction with ring <br/ ><br>-Participants who plan to continue use of ring <br/ ><br>-Participants who would recommend ringTimepoint: 3 cycles (1 cycle is 28 days)

Secondary Outcome Measures

Name	Time	Method
umber of adverse events reported during the studyTimepoint: 3 cycles (1 cycle is 28 days);Number of pregnancy or pregnancies due to contraceptive method failure during the studyTimepoint: 3 cycles (1 cycle is 28 days);Number of serious adverse events during the studyTimepoint: 3 cycles (1 cycle is 28 days)