Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
1 other identifier
interventional
523
0 countries
N/A
Brief Summary
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated 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_3
Started Sep 2003
Typical duration for phase_3
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
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedMay 29, 2008
May 1, 2008
3.3 years
September 7, 2005
May 27, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
Month 12
Secondary Outcomes (8)
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
Month 6
Change from baseline in menstrual pictogram bleeding score.
Final Month
Change from baseline in the number of days with bleeding.
Final Month
Change from baseline in hemoglobin concentration.
Final Visit
Percent change from baseline in the volume of the largest fibroid.
Final Visit
- +3 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
- Otherwise in good health
- Premenopausal based on Estrogen and FSH levels
- Agrees to use of double barrier method of contraception
- Adequate endometrial biopsy with no significant histological disorder
You may not qualify if:
- Any abnormal lab or procedure result(s) the study-doctor considers important
- Significant gynecological disorder such as confirmed endometrial polyp
- Hemoglobin \< 8.0 g/dL
- History of a blood-clotting disorder
- Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Related Publications (1)
Diamond MP, Stewart EA, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. A 12-month extension study to evaluate the safety and efficacy of asoprisnil in women with heavy menstrual bleeding and uterine fibroids. Hum Reprod Open. 2019 Nov 4;2019(4):hoz027. doi: 10.1093/hropen/hoz027. eCollection 2019.
PMID: 31777761DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Medical Director
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
September 1, 2003
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
May 29, 2008
Record last verified: 2008-05