Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344383
Status:
COMPLETED
Last Update Posted:
2011-03-04
First Post:
2006-06-23
Brief Title:
An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With NorgestimateEthinyl Estradiol Tablets Administered as an Extended 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:
An Open-Label Study Evaluating the Bleeding Profile of Ortho Tri-Cyclen Lo NorgestimateEthinyl Estradiol Administered as an Extended Regimen
Status:
COMPLETED
Status Verified Date:
2011-03
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 evaluate the bleeding profile of norgestimateethinyl estradiol an oral contraceptive tablet given in an extended regimen
Detailed Description:
This is an open-label study evaluating the bleeding profile of norgestimateethinyl estradiol tablets administered as an extended regimen 84 consecutive days of active tablets followed by seven days medication free following a traditional regimen of two 28-day cycles 21 days of active tablets followed by seven days of placebo tablets of norgestimateethinyl estradiol tablets All patients will receive norgestimateethinyl estradiol tablets in a traditional regimen for two 28-day cycles Following the Traditional Treatment Phase all patients will receive norgestimateethinyl estradiol tablets in an Extended Regimen Treatment Phase consisting of 84 days of treatment with norgestimateethinyl estradiol tablets Safety evaluations include physical examinations adverse event reporting and vital signs The hypothesis of the study is that a triphasic extended regimen would not result in breakthrough bleeding and spotting when the progestin dose drops Traditional Regimen two 28 day cycles of norgestimate 180 mcg daily for 1 week 215 mcg daily for 1 week 250 mcg daily for 1 week placebo daily for 1 week Extended Regimen four uninterrupted cycles of norgestimate 180 mcg daily for 1 week 215 mcg daily for 1 week 250 mcg daily for 1 week 1 week medication-free In both Treatment Regimens patients receive ethinyl estradiol 25 mcg in each active tablet The study is 147 days Traditional days 1-56 and Extended days 57-147
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