Back to resultsA Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
Primary Purpose
Leiomyoma, Menorrhagia, Metrorrhagia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Asoprisnil
Asoprisnil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Leiomyoma focused on measuring Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage, asoprisnil
Eligibility Criteria
Inclusion Criteria: Premenopausal women History of regular menstrual cycles (21-42 days) Diagnosis of uterine fibroid(s) Abnormal vaginal bleeding associated with uterine fibroids Otherwise in good health Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails Negative pregnancy test Agrees to Double-barrier method of contraception Pap smear with no evidence of malignancy or pre-malignant changes Endometrial biopsy with no significant histological disorder Exclusion Criteria: Any abnormal lab or procedure result the study-doctor considers important Severe reaction(s) to or are currently using any hormone therapy History of osteoporosis or other bone disease Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months History of Polycystic Ovary Syndrome or prolactinoma MRI shows significant gynecologic disorder Uterine size > 25 weeks gestation Hemoglobin < 8 g/dL at Day -1
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
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.
Secondary Outcome Measures
Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.
Change from baseline in menstrual pictogram score.
Change from baseline in number of days with bleeding.
Change from baseline in hemoglobin concentration.
Percent change from baseline in volume of the largest fibroid.
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.
Change from baseline in total symptom severity score and UFS-QOL total score.
Cumulative percent of subjects who achieve amenorrhea.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00160381
Brief Title
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
Official Title
A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.
Detailed Description
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma, Menorrhagia, Metrorrhagia
Keywords
Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage, asoprisnil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
432 (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
Intervention Description
10mg Tablet, oral Daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Asoprisnil
Intervention Description
25 mg Tablet, oral Daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, oral Daily for 12 months
Primary Outcome Measure Information:
Title
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.
Time Frame
Month 12 or Final Visit
Secondary Outcome Measure Information:
Title
Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.
Time Frame
Month 6
Title
Change from baseline in menstrual pictogram score.
Time Frame
Final Month
Title
Change from baseline in number of days with bleeding.
Time Frame
Final Month
Title
Change from baseline in hemoglobin concentration.
Time Frame
Final Visit
Title
Percent change from baseline in volume of the largest fibroid.
Time Frame
Final Visit
Title
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.
Time Frame
Final Visit
Title
Change from baseline in total symptom severity score and UFS-QOL total score.
Time Frame
Final Visit
Title
Cumulative percent of subjects who achieve amenorrhea.
Time Frame
Month 3
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal women
History of regular menstrual cycles (21-42 days)
Diagnosis of uterine fibroid(s)
Abnormal vaginal bleeding associated with uterine fibroids
Otherwise in good health
Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
Negative pregnancy test
Agrees to Double-barrier method of contraception
Pap smear with no evidence of malignancy or pre-malignant changes
Endometrial biopsy with no significant histological disorder
Exclusion Criteria:
Any abnormal lab or procedure result the study-doctor considers important
Severe reaction(s) to or are currently using any hormone therapy
History of osteoporosis or other bone disease
Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
History of Polycystic Ovary Syndrome or prolactinoma
MRI shows significant gynecologic disorder
Uterine size > 25 weeks gestation
Hemoglobin < 8 g/dL at Day -1
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
30865281
Citation
Stewart EA, Diamond MP, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. Safety and efficacy of the selective progesterone receptor modulator asoprisnil for heavy menstrual bleeding with uterine fibroids: pooled analysis of two 12-month, placebo-controlled, randomized trials. Hum Reprod. 2019 Apr 1;34(4):623-634. doi: 10.1093/humrep/dez007.
Results Reference
derived
PubMed Identifier
23188490
Citation
Larsen L, Coyne K, Chwalisz K. Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding. Reprod Sci. 2013 Jun;20(6):680-7. doi: 10.1177/1933719112463252. Epub 2012 Nov 27.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
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