Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258076
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2005-11-22
Brief Title:
A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA a Transdermal Contraceptive Patch
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Open-Label Randomized Partially Balanced Incomplete Block Design Sudy to Evaluate the Hormone Exposure From Commercial ORTHO EVRA
Status:
COMPLETED
Status Verified Date:
2012-12
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 objective of this study is to estimate the exposure to the hormones norelgestromin norgestrel and ethinyl estradiol in the bloodstream of healthy female volunteers across multiple commercial lots of ORTHO EVRAÂ a transdermal contraceptive patch and to compare these data to historical hormonal exposure data from one ORTHO EVRAÂ clinical development lot
Detailed Description:
This multicenter open-label randomized partially-balanced incomplete block design study will consist of a pre-treatment phase a screening period lasting up to 21 days an open-label treatment phase three 7-day treatment periods separated by 21-day washouts and a post-treatment phase a follow-up or early withdrawal visit Total participation in the study is approximately 67 days Approximately 52 subjects will be enrolled The study population comprises healthy women ages 18 to 45 years inclusive who weigh at least 110 pounds have a body mass index BMI between 16 and 299 kg per meter squared
An ORTHO EVRA patch from 1 of the 13 selected commercial lots will be applied to the buttock of each subject and worn for 7 days Patches will be applied on Days 1 29 and 57 by the investigator or designated study unit personnel Each patch will be worn on the upper outer quadrant of the same buttock but the 3 patches will not necessarily be placed in the exact same position The investigator or designated study unit personnel will remove the patches on Days 8 36 and 64 and will evaluate the adhesion of the patches before removal
Subjects will be confined to the study unit for blood sample collections for determination of NGMN NG and EE serum concentrations Blood samples will be collected via venipuncture immediately before and at specified time points after each patch application Pharmacokinetic parameters of NGMN NG and EE including Cmax tmax and AUC for each treatment will be estimated by standard methods Safety will be assessed throughout the study and will be based on adverse events and changes in physical and gynecologic examinations including breast examinations vital signs electrocardiograms ECGs and clinical laboratory test results Three 7-day treatment periods separated by 21-day washouts as follows Each ORTHO EVRA patch will be worn on the buttock upper outer quadrant for 7 days Twenty one days after completing each treatment subjects will cross over to the next treatment for 7 days The patch will be applied to the upper outer quadrant of the same buttock as before but not necessarily in the exact same spot
An ORTHO EVRA patch from 1 of the 13 selected commercial lots will be applied to the buttock of each subject and worn for 7 days Patches will be applied on Days 1 29 and 57 by the investigator or designated study unit personnel Each patch will be worn on the upper outer quadrant of the same buttock but the 3 patches will not necessarily be placed in the exact same position The investigator or designated study unit personnel will remove the patches on Days 8 36 and 64 and will evaluate the adhesion of the patches before removal
Subjects will be confined to the study unit for blood sample collections for determination of NGMN NG and EE serum concentrations Blood samples will be collected via venipuncture immediately before and at specified time points after each patch application Pharmacokinetic parameters of NGMN NG and EE including Cmax tmax and AUC for each treatment will be estimated by standard methods Safety will be assessed throughout the study and will be based on adverse events and changes in physical and gynecologic examinations including breast examinations vital signs electrocardiograms ECGs and clinical laboratory test results Three 7-day treatment periods separated by 21-day washouts as follows Each ORTHO EVRA patch will be worn on the buttock upper outer quadrant for 7 days Twenty one days after completing each treatment subjects will cross over to the next treatment for 7 days The patch will be applied to the upper outer quadrant of the same buttock as before but not necessarily in the exact same spot
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