Clinical trial
Contraceptive Vaginal Ring Releasing Etonogestrel and Ethinylestradiol (NuvaRing): Cycle Control, Acceptability and Tolerability Study in Indian Women
Name
P07733
Description
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.
Trial arms
Trial start
2011-12-26
Estimated PCD
2012-12-05
Trial end
2012-12-05
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
NuvaRing
Other names:
NuvaRing, SCH 900702
Size
252
Primary endpoint
Number of Participants With Regular Menstrual Cycles
Up to 84 days (three 28-day cycles)
Average Number of Bleeding Days Per Cycle
Up to 84 days (three 28-day cycles)
Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring
Up to 84 days (three 28-day cycles)
Number of Participants With Intermenstrual Bleeding/Spotting
Up to 84 days (three 28-day cycles)
Number of Bleeding Days Per Cycle
Up to 84 days (three 28-day cycles)
Number of Spotting Days Per Cycle
Up to 84 days (three 28-day cycles)
Participants' Assessment of Ease of Insertion of Vaginal Ring
Up to 84 days (three 28-day cycles)
Participants' Assessment of Ease of Removal of Vaginal Ring
Up to 84 days (three 28-day cycles)
Participants' Assessment of Feeling Vaginal Ring at Any Time
Up to 84 days (three 28-day cycles)
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Up to 84 days (three 28-day cycles)
Frequency of Partner Feeling Vaginal Ring During Intercourse
Up to 84 days (three 28-day cycles)
Frequency of Partner Objecting to Vaginal Ring Use
Up to 84 days (three 28-day cycles)
Participants' Overall Satisfaction With Vaginal Ring
Up to 84 days (three 28-day cycles)
Number of Participants Who Plan to Continue Using Vaginal Ring
Up to 84 days (three 28-day cycles)
Number of Participants Who Would Recommend Vaginal Ring to Others
Up to 84 days (three 28-day cycles)
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 252, 'type': 'ACTUAL'}}
Updated at
2024-05-24
1 organization
1 product
1 indication
Organization
Organon and CoIndication
Contraception