Back to resultsA Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy
Primary Purpose
Uterine Fibroids, Leiomyoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Asoprisnil
Asoprisnil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring Fibroid Uterus, Leiomyoma, Uterine Fibroids, Hysterectomy, Asoprisnil
Eligibility Criteria
Inclusion Criteria: Premenopausal women, at least 18 years of age Diagnosis of uterine fibroid(s), confirmed by ultrasound History of menstrual cycles between 17 and 42 days Otherwise in good health Scheduled for a hysterectomy at the end of the treatment period Negative pregnancy test Agrees to double barrier method of contraception Pap test with no evidence of malignancy or pre-malignant changes Endometrial biopsy with no significant histological disorder 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 or are currently using any hormone therapy History of cancer or alcohol or drug abuse Diagnosis of Polycystic Ovary Syndrome History of prolactinoma Current use of Intrauterine Device Significant gynecological disorder Uterine size > 32 weeks gestation Current diagnosis of endometriosis Uterine artery embolization within 6 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
Secondary Outcome Measures
Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index.
Morphological changes in the endometrium, myometrium and uterine fibroids.
Change from baseline in menstrual pictogram score.
Percent change from baseline in volume of the largest fibroid.
Endometrial thickness (post-treatment histologic evaluation).
Change from baseline in endometrial thickness by transvaginal ultrasound.
Percent of ovulatory subjects.
Change from baseline in the Uterine Fibroid Symptom-Quality of Life total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00150644
Brief Title
A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy
Official Title
A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.
Detailed Description
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Leiomyoma
Keywords
Fibroid Uterus, Leiomyoma, Uterine Fibroids, Hysterectomy, Asoprisnil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Asoprisnil
Other Intervention Name(s)
J867
Intervention Description
Asoprisnil 10mg Tablet, oral Daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Asoprisnil
Other Intervention Name(s)
J867
Intervention Description
Asoprisnil 25 mg Tablet, oral Daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Tablet, oral Daily for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
Time Frame
Final visit
Secondary Outcome Measure Information:
Title
Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index.
Time Frame
Final Visit
Title
Morphological changes in the endometrium, myometrium and uterine fibroids.
Time Frame
Final Visit
Title
Change from baseline in menstrual pictogram score.
Time Frame
Final Month
Title
Percent change from baseline in volume of the largest fibroid.
Time Frame
Final Visit
Title
Endometrial thickness (post-treatment histologic evaluation).
Time Frame
Final Visit
Title
Change from baseline in endometrial thickness by transvaginal ultrasound.
Time Frame
Final Visit
Title
Percent of ovulatory subjects.
Time Frame
Final Month
Title
Change from baseline in the Uterine Fibroid Symptom-Quality of Life total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
Time Frame
Final Visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal women, at least 18 years of age
Diagnosis of uterine fibroid(s), confirmed by ultrasound
History of menstrual cycles between 17 and 42 days
Otherwise in good health
Scheduled for a hysterectomy at the end of the treatment period
Negative pregnancy test
Agrees to double barrier method of contraception
Pap test with no evidence of malignancy or pre-malignant changes
Endometrial biopsy with no significant histological disorder
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 or are currently using any hormone therapy
History of cancer or alcohol or drug abuse
Diagnosis of Polycystic Ovary Syndrome
History of prolactinoma
Current use of Intrauterine Device
Significant gynecological disorder
Uterine size > 32 weeks gestation
Current diagnosis of endometriosis
Uterine artery embolization within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Abbott
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
17339234
Citation
Williams AR, Critchley HO, Osei J, Ingamells S, Cameron IT, Han C, Chwalisz K. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod. 2007 Jun;22(6):1696-704. doi: 10.1093/humrep/dem026. Epub 2007 Mar 5.
Results Reference
result
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A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy
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