Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258063
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-11-22
Brief Title:
A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme and CILEST an Oral Contraceptive
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 Study to Evaluate the Hormone Exposure From Commercial EVRA Manufactured by LOHMANN Therapie-Systeme and an Oral Contraceptive
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 exposure to the hormones norelgestromin norgestrel and ethinyl estradiol in healthy female volunteers across multiple commercial lots of EVRAÂ a transdermal contraceptive patch manufactured by LOHMANN Therapie-Systeme to compare these data to exposure data from one clinical lot and to compare these data to exposure data from a commercially available oral contraceptive
Detailed Description:
This single-center 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 54 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
Subjects will wear an EVRA patch or take CILEST during each of the three 7-day treatment periods treatment periods will be separated by a 21-day washout period When a subject is to wear EVRA a patch from 1 of the 6 selected commercial lots will be applied on the buttock and worn for 7 days Patches will be applied by the investigator or designated study unit personnel All patches will be worn on the upper outer quadrant of the same buttock but not necessarily in the exact same position The investigator or designated study unit personnel will remove the patches and will evaluate the adhesion of the patches before removal When a subject is to receive CILEST tablets from 1 of the 3 selected commercial lots will be administered daily for 7 consecutive days A minimum of 21 days after removal of the patch or the seventh dose of CILEST the subject will begin another treatment period until she completes 3 open-label treatment periods
Subjects will be confined to the study unit for blood sample collections for determination of NGMN NG and EE plasma concentrations Blood samples will be collected via venipuncture immediately before each dose and at specified time points after each dose is administered Pharmacokinetic parameters of NGMN NG and EE including Cmax tmax and AUC after 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 treatments separated by 21-day washout Based on the randomization schedule some subjects will wear an EVRA patch in all 3 periods on the upper outer quadrant of the buttock for 7 days some will wear a patch in 2 periods and take CILEST oral tablets once daily in 1 period and some will wear a patch in 1 period and take CILEST oral tablets once daily in 2 periods
Subjects will wear an EVRA patch or take CILEST during each of the three 7-day treatment periods treatment periods will be separated by a 21-day washout period When a subject is to wear EVRA a patch from 1 of the 6 selected commercial lots will be applied on the buttock and worn for 7 days Patches will be applied by the investigator or designated study unit personnel All patches will be worn on the upper outer quadrant of the same buttock but not necessarily in the exact same position The investigator or designated study unit personnel will remove the patches and will evaluate the adhesion of the patches before removal When a subject is to receive CILEST tablets from 1 of the 3 selected commercial lots will be administered daily for 7 consecutive days A minimum of 21 days after removal of the patch or the seventh dose of CILEST the subject will begin another treatment period until she completes 3 open-label treatment periods
Subjects will be confined to the study unit for blood sample collections for determination of NGMN NG and EE plasma concentrations Blood samples will be collected via venipuncture immediately before each dose and at specified time points after each dose is administered Pharmacokinetic parameters of NGMN NG and EE including Cmax tmax and AUC after 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 treatments separated by 21-day washout Based on the randomization schedule some subjects will wear an EVRA patch in all 3 periods on the upper outer quadrant of the buttock for 7 days some will wear a patch in 2 periods and take CILEST oral tablets once daily in 1 period and some will wear a patch in 1 period and take CILEST oral tablets once daily in 2 periods
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