A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00160459
• Collaborator: (none)
• Enrollment: 129
• Arms: 4
• Duration (Months): 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leiomyoma	Drug: Asoprisnil; Drug: Asoprisnil; Drug: Asoprisnil; Drug: Placebo	Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 129 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2000
• Actual Primary Completion Date: Jul 1, 2001
• Actual Study Completion Date: Jul 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Asoprisnil; 5 mg Tablet, oral Daily for 12 weeks
Experimental: 2	Drug: Asoprisnil; 10 mg Tablet, oral Daily for 12 weeks
Experimental: 3	Drug: Asoprisnil; 25 mg Tablet, oral Daily for 12 weeks
Placebo Comparator: 4	Drug: Placebo; Tablet, oral Daily for 12 weeks

Outcome Measures

Primary Outcome Measures

1. 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.]

2. Duration of amenorrhea [Day 1 to 1st post treatment menses]

Secondary Outcome Measures

1. Change from baseline in uterine size in gestational weeks. [Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6]

2. Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume. [Week 12 and final visit]

3. Percentage of days with bleeding. [Day 1 through end of 1st post-treatment menses]

4. Changes in hematologic and iron parameters. [Baseline to each visit]

5. Uterine fibroid symptom improvement. [Baseline to each visit]

6. Response to Global Efficacy Question regarding improvement in fibroid symptoms. [Week 12 and Final Visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 48 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Abbott

Investigators

• Study Chair: Medical Director, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00160459
• Other Study ID Numbers: M99-144
• First Posted: Sep 12, 2005
• Last Update Posted: May 29, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: Fibroid Uterus; Leiomyoma; Uterine Fibroids; asoprisnil
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

No Results Posted as of May 29, 2008