None listed
Conditions
Interventions
Intervention1: 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 d
Sponsors
Merck Sharp and Dohme
Organon India Limited a subsidiary of Merck and Co Inc Whitehouse Station NJ USA
Eligibility
Inclusion criteria
Inclusion criteria: There is no upper age limit specified for this study Women at risk of pregnancy and seeking contraception
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Participants with regular menstrual cycles -Participants with breakthrough bleeding/spotting -Average number of bleeding days, pads used per day and bleeding/spotting days -Assessment of ease of insertion and removal -Frequency of feeling ring at any time or during intercourse -Frequency of partner feeling ring during intercourse or of objection to ring use -Participants overall satisfaction with ring -Participants who plan to continue use of ring -Participants who would recommend ringTimepoint: 3 cycles (1 cycle is 28 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number 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) | — |
Countries
India
Contacts
Public ContactDr Viraj Salgoankar
MSD Pharmaceutical Pvt Ltd
Outcome results
None listed