Clinical trial NCT00160459: A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leiomyoma
Keywords: Fibroid Uterus
Leiomyoma
Uterine Fibroids
asoprisnil
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study

Eligibility criteria: 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

Primary outcomes:
measure: Percent change from baseline in uterine volume and volume of the largest fibroid.
timeFrame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
measure: Duration of amenorrhea
timeFrame: Day 1 to 1st post treatment menses
Secondary outcomes:
measure: Change from baseline in uterine size in gestational weeks.
timeFrame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6
measure: Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.
timeFrame: Week 12 and final visit
measure: Percentage of days with bleeding.
timeFrame: Day 1 through end of 1st post-treatment menses
measure: Changes in hematologic and iron parameters.
timeFrame: Baseline to each visit
measure: Uterine fibroid symptom improvement.
timeFrame: Baseline to each visit
measure: Response to Global Efficacy Question regarding improvement in fibroid symptoms.
timeFrame: Week 12 and Final Visit
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Medical Director
role: STUDY_CHAIR
References:
citation: 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.