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

Organon and Co252 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

252

Conditions

Contraception

Interventions

Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Regular Menstrual Cycles

The number of participants who experienced regular menstrual bleeding patterns throughout the period of NuvaRing use. Bleeding patterns were to be characterized by particpants as regular or irregular.

Time frame: Up to 84 days (three 28-day cycles)

Average Number of Bleeding Days Per Cycle

Mean duration of menstruation, per day, per cycle, during the study period.

Time frame: Up to 84 days (three 28-day cycles)

Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring

Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.

Time frame: Up to 84 days (three 28-day cycles)

Number of Participants With Intermenstrual Bleeding/Spotting

Number of participants who experienced vaginal bleeding, which includes BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. Vaginal bleeding that required \>=2 pads per day was classified as BLEEDING. Vaginal bleeding that required \<=1 pad per day was classified as SPOTTING.

Time frame: Up to 84 days (three 28-day cycles)

Number of Bleeding Days Per Cycle

Intermenstrual vaginal bleeding that required \>=2 pads per day was classified as BLEEDING.

Time frame: Up to 84 days (three 28-day cycles)

Number of Spotting Days Per Cycle

Intermenstrual vaginal bleeding that required \<=1 pad per day was classified as SPOTTING.

Time frame: Up to 84 days (three 28-day cycles)

Participants' Assessment of Ease of Insertion of Vaginal Ring

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of Pregnancies Due to Contraceptive Method Failure During the Study

For participants with suspected pregnancy during in-treatment period, pregnancy was to be confirmed by hCG qualitative analysis using strip and/or other test(s) at the discretion of the treating physician.

Time frame: Up to 84 days (three 28-day cycles)

Number of Participants Who Reported at Least One Adverse Event During the Study

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic, or medical device, which does not necessarily have a causal relationship with the treatment.

Time frame: Up to 84 days (three 28-day cycles)

Number of Participants Who Reported a Serious Adverse Event During the Study

A serious adverse event is any adverse drug or biologic or device experience that results in death, a life-threatening adverse event, persistent or significant disability or incapacity; requires in-patient hospitalization, or prolonged hospitalization; or causes a congenital anomaly or birth defect.

Time frame: Up to 84 days (three 28-day cycles)