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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00160381

Purpose

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

Condition	Intervention	Phase
Leiomyoma Menorrhagia Metrorrhagia	Drug: Asoprisnil Drug: Placebo	Phase III

MedlinePlus related topics: Vaginal Bleeding

Drug Information available for: 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 III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.

Further study details as provided by Abbott:

Primary Outcome Measures:

The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention. [ Time Frame: Month 12 or Final Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change from baseline in menstrual pictogram score. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
Change from baseline in number of days with bleeding. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
Change from baseline in hemoglobin concentration. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Percent change from baseline in volume of the largest fibroid. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in total symptom severity score and UFS-QOL total score. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Cumulative percent of subjects who achieve amenorrhea. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Enrollment:	432
Study Start Date:	September 2002
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Asoprisnil 10mg Tablet, oral Daily for 12 months
2: Experimental	Drug: Asoprisnil 25 mg Tablet, oral Daily for 12 months
3: Placebo Comparator	Drug: Placebo Tablet, oral Daily for 12 months

Detailed Description:

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

Eligibility

Ages Eligible for Study:	18 Years and older
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
Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
Negative pregnancy test
Agrees to Double-barrier method of contraception
Pap smear with no evidence of malignancy or pre-malignant changes
Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

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
Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
History of Polycystic Ovary Syndrome or prolactinoma
MRI shows significant gynecologic disorder
Uterine size > 25 weeks gestation
Hemoglobin < 8 g/dL at Day -1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160381

Sponsors and Collaborators

Abbott

Investigators

Study Chair:

Medical Director

Abbott

More Information

Responsible Party:	Abbott ( Cynthia Mattia-Goldberg )
Study ID Numbers:	M01-394
Study First Received:	September 8, 2005
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00160381
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Abbott:

Symptomatic Uterine Fibroids
Excessive Uterine Bleeding
Uterine Hemorrhage
asoprisnil

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 January 16, 2009