Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320580
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2006-04-28
Brief Title:
An Open-Label Study to Compare the Bleeding Profile of NorelgestrominEthinyl Estradiol in an Extended Regimen to NorelgestrominEthinyl Estradiol Given in a Traditional Regimen
Sponsor:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Organization:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Study Overview
Official Title:
A Randomized Open-Label Multicenter Study Comparing the Bleeding Profile of Ortho Evra NorelgestrominEthinyl Estradiol Continuous Regimen vs Ortho Evra Cyclic Regimen
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the bleeding profile of norelgestrominethinyl estradiol given in an extended continuous regimen to norelgestrominethinyl estradiol given in a traditional cyclic regimen
Detailed Description:
Norelgestrominethinyl 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 one patch-free week This cyclic method is followed in order to mimic the 28-day menstrual cycle An extended contraceptive regimen administration of active hormones for greater than 21 days of oral contraceptives is a common practice among women wishing to delay or prevent withdrawal bleeding for reasons such as athletic participation or going on vacation In addition to the convenience of reducing the frequency of withdrawal bleeds elimination of the hormone-free interval reportedly reduces many menstrually-related symptoms headaches pelvic pain breast tenderness bloating swelling that occur at a greater frequency during the hormone-free interval than during the rest of the cycle Headache is one of the most common adverse effects associated with hormonal contraceptive use Studies have demonstrated that headaches were reduced in subjects using extended intervals of active hormone However one of the main side effects reported with extended regimens is breakthrough bleeding andor spotting Compared to cyclic regimens extended oral contraceptive use may be associated with an increased incidence of breakthrough bleeding and spotting especially during the first few months of use This is a randomized patients are assigned different treatments based on chance open-label multicenter study comparing the bleeding profile of norelgestrominethinyl estradiol patch continuous regimen to norelgestrominethinyl estradiol patch cyclic regimen Safety evaluations include adverse event reporting physical examinations blood levels and vital signs The hypothesis of the study is that norelgestrominethinyl estradiol in an extended regimen of 84 days of active hormone would result in fewer days and episodes of bleeding compared to a traditional cyclic regimen of norelgestrominethinyl estradiol Patients receive norelgestrominethinyl estradiol patches in a plastic sleeve In the extended regimen patches will be applied weekly for 12 consecutive weeks followed by one week patch-free and then another three consecutive weeks of weekly patch applications In the cyclic regimen patches will be applied for four consecutive cycles where each cycle consists of three weekly patch applications followed by one week patch-free The total duration of treatment period is 112 days for each regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None