Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331123
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 Efficacy and Safety of Transdermal Testosterone and Safety for an Open-label Period in Women With Hypoactive Sexual Desire Disorder on 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 52-week multicenter multinational study that included a 24-week double-blind DB parallel-group placebo-controlled period followed by a 28-week open-label OL period 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 Upon completion of the DB period patients receiving placebo were switched to TTS while the active cohort remained on active treatment All patients were then followed for an additional 28 weeks for safety Patients who completed the first 52 weeks of the study were given the opportunity to participate in an open label extension Years 2 3 and 4 which was added to the protocol by amendment Safety was assessed by adverse events lipids serum chemistry with hepatic renal and carbohydrate metabolism evaluation coagulation testing 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