Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331214
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2006-05-26
Brief Title:
Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
Sponsor:
Warner Chilcott
Organization:
Warner Chilcott
Study Overview
Official Title:
Study to Evaluate the Efficacy and Safety of Transdermal Testosterone in Women With Hypoactive Sexual Desire Disorder on Concurrent Estrogen Replacement Therapy and Undergone HysterectomyBilateral Oophorectomy
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 surgically menopausal women who are taking estrogen therapy
Detailed Description:
Women with hypoactive sexual desire disorder HSDD who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 24-week multicenter multinational double-blind DB parallel-group placebo-controlled study Patients were stratified based on their use of oral or transdermal ET and randomized to receive placebo or testosterone transdermal system Patients had to maintain a stable dose of estrogen throughout the study Patients who completed the first 24 weeks of the study were given the opportunity to participate in a 35 year open-label active treatment study extension which was added to the protocol by amendment 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