Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349791
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2006-07-07
Brief Title:
Study to Assess the EfficacySafety of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
Sponsor:
Warner Chilcott
Organization:
Warner Chilcott
Study Overview
Official Title:
A Study to Evaluate the EfficacySafety of Transdermal Testosterone for 24 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy
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 study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in naturally menopausal women who are taking estrogen or estrogenprogestin therapy
Detailed Description:
Naturally menopausal women with hypoactive sexual desire disorder HSDD were randomized into a 24-week multicenter multinational double-blind DB parallel-group placebo-controlled study Patients were randomized to receive a placebo or testosterone transdermal system throughout the study Safety was assessed by adverse events lipids serum chemistry with hepatic renal and carbohydrate metabolism evaluation and hematology Physical exam including clinical assessments of facial hair and acne were monitored
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