Leiomyoma Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
Verified date | May 2008 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug AdministrationCanada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 129 |
Est. completion date | July 2001 |
Est. primary completion date | July 2001 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Abbott |
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. Epub 2007 F — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No | |
Primary | Duration of amenorrhea | Day 1 to 1st post treatment menses | No | |
Secondary | Change from baseline in uterine size in gestational weeks. | Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6 | No | |
Secondary | Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume. | Week 12 and final visit | No | |
Secondary | Percentage of days with bleeding. | Day 1 through end of 1st post-treatment menses | No | |
Secondary | Changes in hematologic and iron parameters. | Baseline to each visit | Yes | |
Secondary | Uterine fibroid symptom improvement. | Baseline to each visit | No | |
Secondary | Response to Global Efficacy Question regarding improvement in fibroid symptoms. | Week 12 and Final Visit | No |
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