A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids - Full Text View

Purpose

The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.

Condition	Intervention	Phase
Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids	Drug: Asoprisnil Drug: Placebo	Phase III

ChemIDplus related topics:

Asoprisnil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata

Further study details as provided by Abbott:

Primary Outcome Measures:

Cumulative percent of subjects achieving amenorrhea. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in the Work Limitation Questionnaire Index. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary). [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in the monthly bleeding score. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in the hemoglobin concentration. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in volume of the largest fibroid. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment. [ Time Frame: During treatment period ] [ Designated as safety issue: No ]
Percentage of subjects who respond positively to the global efficacy question. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]

Enrollment:	239
Study Start Date:	September 2003
Study Completion Date:	February 2005
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Asoprisnil Asoprisnil 10 mg Tablet, oral Daily for 6 months
2: Experimental	Drug: Asoprisnil Asoprisnil 25mg Tablet, oral Daily for 6 months
3: Placebo Comparator	Drug: Placebo Placebo Tablet, oral Daily for 6 months

Detailed Description:

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.

Eligibility

Ages Eligible for Study:	18 Years to 53 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Premenopausal women
History of regular menstrual cycles (21-42 days)
Diagnosis of uterine fibroid(s)
Abnormal vaginal bleeding associated with uterine fibroids
Otherwise in good health
Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3

Exclusion Criteria:

Less than 3 months postpartum and post-lactation
Previous myomectomy within 1 year
Any abnormal lab or procedure result the study-doctor considers important
Severe reaction(s) to or are currently using any hormone therapy
History of osteoporosis or other bone disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152256

Sponsors and Collaborators

Abbott

Investigators


Study Chair:	Medical Director	Abbott

More Information

Responsible Party:	Abbott ( Cynthia Mattia-Goldberg )
Study ID Numbers:	C02-037
First Received:	September 7, 2005
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00152256
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Symptomatic Uterine Fibroids

Excessive Uterine Bleeding

Uterine Hemorrhage

Study placed in the following topic categories:

Genital Diseases, Female

Neoplasms, Connective and Soft Tissue

Myofibroma

Menstruation Disturbances

Metrorrhagia

Uterine Hemorrhage

Connective Tissue Diseases

Uterine Diseases

Menorrhagia

Hemorrhage

Leiomyoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue

Neoplasms

Pathologic Processes

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00152256