Ignite Creation Date:
2025-12-17 @ 4:12 PM
Ignite Modification Date:
2025-12-23 @ 11:42 PM
Study NCT ID:
NCT00791856
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2008-11-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch
Sponsor:
Warner Chilcott
Organization:
Study Overview
Official Title:
An Open-label, Multiple-dose, Randomized, Two-period Crossover Study to Assess Bioequivalence of the 300 Mcg/Day Testosterone Reduced-size Patch (14 cm2) Relative to the 300 Mcg/Day Testosterone Reference Patch (28 cm2)
Status:
COMPLETED
Status Verified Date:
2013-04
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:
This is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy (i.e., estrogen for surgically postmenopausal women or a continuous regimen of estrogen plus progestin for naturally postmenopausal women) restricted to approved oral or transdermal regimens only, or not on concomitant hormone therapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: