Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160433
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2005-09-08
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Women With Endometriosis
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Phase II 3-Month Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Three Doses of J867 05 15 and 5 mg QD Versus Placebo in Subjects With Endometriosis
Status:
COMPLETED
Status Verified Date:
2008-05
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 determine the safety and efficacy of 3 asoprisnil doses 05 mg 15 mg and 50 mg for 12 weeks in women with endometriosis
Detailed Description:
Endometriosis the presence of endometrial tissue outside the uterus is a progressive estrogen-dependent disease that occurs in menstruating women of reproductive age Although all major endometriosis therapies are effective for the treatment of pain no single treatment is superior to others in terms of efficacy The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis The objective of this study is to determine if a dose-response relationship exists between asoprisnil and endometriosis-associated pelvic pain and dysmenorrhea or to establish the lowest effective dose of asoprisnil in the treatment of pelvic pain and dysmenorrhea associated with endometriosis Women with surgically confirmed endometriosis will be administered asoprisnil 05 15 and 5 mg tablets or a placebo once daily for 3 months and efficacy will be assessed by improvement in pelvic pain dysmenorrhea dyspareunia bleeding analgesic use global efficacy and quality of life questionnaires Safety will be based on assessments of the endometrium lipid profiles adverse events and changes from baseline laboratory values and vital signs
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