Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: Contraceptive Vaginal Ring Releasing Etonogestrel and Ethinylestradiol (NuvaRing): Cycle Control, Acceptability and Tolerability Study in Indian Women
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Number of Participants With Regular Menstrual CyclesAverage Number of Bleeding Days Per Cycle Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring Number of Participants With Intermenstrual Bleeding/Spotting Number of Bleeding Days Per Cycle Number of Spotting Days Per Cycle Participants' Assessment of Ease of Insertion of Vaginal Ring Participants' Assessment of Ease of Removal of Vaginal Ring Participants' Assessment of Feeling Vaginal Ring at Any Time Participants' Assessment of Feeling Vaginal Ring During Intercourse Frequency of Partner Feeling Vaginal Ring During Intercourse Frequency of Partner Objecting to Vaginal Ring Use Participants' Overall Satisfaction With Vaginal Ring Number of Participants Who Plan to Continue Using Vaginal Ring Number of Participants Who Would Recommend Vaginal Ring to Others
Secondary outcome: Number of Pregnancies Due to Contraceptive Method Failure During the StudyNumber of Participants Who Reported at Least One Adverse Event During the Study Number of Participants Who Reported a Serious Adverse Event During the Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
MSD Pharmaceuticals Private Ltd., Gurgaon 122002, India
Additional Information
Starting date: December 2011
Last updated: June 8, 2015
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