Status:
COMPLETED
An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen
Lead Sponsor:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Metrorrhagia
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given in a traditional cycl...
Detailed Description
Norelgestromin/ethinyl estradiol is a contraceptive patch shown to be safe and effective for the prevention of pregnancy. The usual treatment regimen is three consecutive seven-day patches followed by...
Eligibility Criteria
Inclusion
- Patients in good health as confirmed by medical history
- not pregnant as demonstrated by negative urine pregnancy test
- completed their last term pregnancy at least 42 days prior to Screening and at least one normal menstrual period since last pregnancy
- not lactating
- post-menarcheal and pre-menopausal
Exclusion
- History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products
- treatment with continuous oral contraception within three months of study
- previous use of contraceptive patch including norelgestromin/ethinyl estradiol
- patients who are amenorrheic (abnormal suppression or absence of menstruation)
- recent history of alcohol or substance abuse
- skin conditions resulting in oily, irritated or damaged skin at potential sites of application
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00320580
End Date
March 1 2003
Last Update
July 1 2011
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