- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00160433
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Women With Endometriosis.
May 27, 2008 updated by: Abbott
A Phase II, 3-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Doses of J867 (0.5, 1.5 and 5 mg QD) Versus Placebo in Subjects With Endometriosis
The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 0.5, 1.5, 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 Type
Interventional
Enrollment (Actual)
131
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Premenopausal women (18-40 years)
- Surgically confirmed endometriosis within 3 years
- History of menstrual cycles between 21 and 35 days
- Moderate or severe pelvic pain OR moderate or severe dysmenorrhea OR moderate or severe pelvic tenderness accompanied by at least mild non-menstrual pelvic pain
- Negative pregnancy test
- Agrees to use double barrier method of contraception
- Pap smear with no evidence of malignancy or pre-malignant changes
- Ultrasound with no significant gynecological disorder.
- Otherwise in good health
Exclusion Criteria:
- Less than 3 months after having a baby or breast-feeding
- Any abnormal lab or procedure result the study-doctor considers important
- Severe reaction(s) to hormone therapy
- Anticipated need for excluded hormonal therapy or unapproved narcotics
- Current use of an IUD
- History or prolactinoma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
0.5 mg Tablet, oral Daily for 12 weeks
1.5 mg Tablet, oral Daily for 12 weeks
5.0 mg Tablet, oral Daily for 12 weeks
|
Experimental: 2
|
0.5 mg Tablet, oral Daily for 12 weeks
1.5 mg Tablet, oral Daily for 12 weeks
5.0 mg Tablet, oral Daily for 12 weeks
|
Experimental: 3
|
0.5 mg Tablet, oral Daily for 12 weeks
1.5 mg Tablet, oral Daily for 12 weeks
5.0 mg Tablet, oral Daily for 12 weeks
|
Placebo Comparator: 4
|
Tablet, oral Daily for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change from baseline in pelvic pain as assessed by daily diary
Time Frame: Final month
|
Final month
|
Mean change from baseline in dysmenorrhea as assessed by daily diary
Time Frame: Final month
|
Final month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in pelvic pain and dysmenorrhea scores from the daily diary.
Time Frame: Months 1,2,3 and Months 1-3
|
Months 1,2,3 and Months 1-3
|
Change from baseline in dyspareunia and the combined pelvic pain/dysmenorrhea scores from the daily diary.
Time Frame: Months 1,2,3 and Months 1-3 and the Final Month
|
Months 1,2,3 and Months 1-3 and the Final Month
|
Change from baseline in the percentage of days with mild or greater combined pelvic pain/dysmenorrhea and moderate or greater combined pelvic pain/dysmenorrhea based on the daily diary.
Time Frame: Months 1,2,3 and Months 1-3 and Final Month
|
Months 1,2,3 and Months 1-3 and Final Month
|
Change from baseline for pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration scores assessed by the modified Biberoglu and Behrman pain scale.
Time Frame: Months 1,2,3 and Final Visit
|
Months 1,2,3 and Final Visit
|
Change from baseline in pelvic pain and dysmenorrhea assessed via the Visual Analog Scale.
Time Frame: Months 1,2,3 and Final Visit
|
Months 1,2,3 and Final Visit
|
Percent of subjects with "Yes" response to Global Efficacy question.
Time Frame: Months 1,2,3 and Final Visit
|
Months 1,2,3 and Final Visit
|
Change from baseline in analgesic use scores.
Time Frame: Months 1,2,3, Months 1-3 and Final Visit
|
Months 1,2,3, Months 1-3 and Final Visit
|
Percent of subjects who achieve amenorrhea.
Time Frame: Throughout the treatment period
|
Throughout the treatment period
|
Change from baseline in Endometriosis Health Profile-30 (EHP-30) scores.
Time Frame: Month 3
|
Month 3
|
Change from baseline in Short Form-36 scores.
Time Frame: Month 3
|
Month 3
|
Change from baseline in both monthly bleeding scores and percentage of days with bleeding or spotting.
Time Frame: Months 1-3
|
Months 1-3
|
Change from Screening menses in bleeding intensity.
Time Frame: First post-treatment menses
|
First post-treatment menses
|
Change from baseline in hemoglobin and hematocrit.
Time Frame: Months 1,2,3 and Final Visit
|
Months 1,2,3 and Final Visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2002
Primary Completion (Actual)
June 1, 2003
Study Completion (Actual)
June 1, 2003
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
May 29, 2008
Last Update Submitted That Met QC Criteria
May 27, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M01-398
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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