Clinical trial NCT01490190: Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)
Official title: Contraceptive Vaginal Ring Releasing Etonogestrel and Ethinylestradiol (NuvaRing): Cycle Control, Acceptability and Tolerability Study in Indian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-12-12
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Regular Menstrual Cycles
timeFrame: Up to 84 days (three 28-day cycles)
measure: Average Number of Bleeding Days Per Cycle
timeFrame: Up to 84 days (three 28-day cycles)
measure: Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring
timeFrame: Up to 84 days (three 28-day cycles)
measure: Number of Participants With Intermenstrual Bleeding/Spotting
timeFrame: Up to 84 days (three 28-day cycles)
measure: Number of Bleeding Days Per Cycle
timeFrame: Up to 84 days (three 28-day cycles)
measure: Number of Spotting Days Per Cycle
timeFrame: Up to 84 days (three 28-day cycles)
measure: Participants' Assessment of Ease of Insertion of Vaginal Ring
timeFrame: Up to 84 days (three 28-day cycles)
measure: Participants' Assessment of Ease of Removal of Vaginal Ring
timeFrame: Up to 84 days (three 28-day cycles)
measure: Participants' Assessment of Feeling Vaginal Ring at Any Time
timeFrame: Up to 84 days (three 28-day cycles)
measure: Participants' Assessment of Feeling Vaginal Ring During Intercourse
timeFrame: Up to 84 days (three 28-day cycles)
measure: Frequency of Partner Feeling Vaginal Ring During Intercourse
timeFrame: Up to 84 days (three 28-day cycles)
measure: Frequency of Partner Objecting to Vaginal Ring Use
timeFrame: Up to 84 days (three 28-day cycles)
measure: Participants' Overall Satisfaction With Vaginal Ring
timeFrame: Up to 84 days (three 28-day cycles)
measure: Number of Participants Who Plan to Continue Using Vaginal Ring
timeFrame: Up to 84 days (three 28-day cycles)
measure: Number of Participants Who Would Recommend Vaginal Ring to Others
timeFrame: Up to 84 days (three 28-day cycles)
Secondary outcomes:
measure: Number of Pregnancies Due to Contraceptive Method Failure During the Study
timeFrame: Up to 84 days (three 28-day cycles)
measure: Number of Participants Who Reported at Least One Adverse Event During the Study
timeFrame: Up to 84 days (three 28-day cycles)
measure: Number of Participants Who Reported a Serious Adverse Event During the Study
timeFrame: Up to 84 days (three 28-day cycles)
Other outcomes:
Locations:
Study officials:
References: