A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
1 other identifier
interventional
129
0 countries
N/A
Brief Summary
This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2000
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedMay 29, 2008
May 1, 2008
1.2 years
September 8, 2005
May 27, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent change from baseline in uterine volume and volume of the largest fibroid.
Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
Duration of amenorrhea
Day 1 to 1st post treatment menses
Secondary Outcomes (6)
Change from baseline in uterine size in gestational weeks.
Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6
Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.
Week 12 and final visit
Percentage of days with bleeding.
Day 1 through end of 1st post-treatment menses
Changes in hematologic and iron parameters.
Baseline to each visit
Uterine fibroid symptom improvement.
Baseline to each visit
- +1 more secondary outcomes
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Women between 18 and 49 years of age
- Diagnosis of either 1 or more uterine fibroids
- History of regular menstrual cycles of 21 to 35 days in length.
You may not qualify if:
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to or current use of hormone therapy
- History of osteoporosis or other bone disease
- History of uterine artery embolization, cryomyolysis, or electrical myolysis
- Subject currently breast feeding
- Hemoglobin \< 8 g/dL at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Related Publications (1)
Chwalisz K, Larsen L, Mattia-Goldberg C, Edmonds A, Elger W, Winkel CA. A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata. Fertil Steril. 2007 Jun;87(6):1399-412. doi: 10.1016/j.fertnstert.2006.11.094. Epub 2007 Feb 20.
PMID: 17307170RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Medical Director
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
May 1, 2000
Primary Completion
July 1, 2001
Study Completion
July 1, 2001
Last Updated
May 29, 2008
Record last verified: 2008-05