Safety of Treatment of Uterine Fibroids With Asoprisnil - Full Text View

Purpose

The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.

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

ChemIDplus related topics:

Asoprisnil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Safety Study

Official Title:	A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Further study details as provided by Abbott:

Primary Outcome Measures:

Long Term Safety [ Time Frame: Throughout 18 month treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cumulative and incremental amenorrhea rates. [ Time Frame: Each month 1-18 ] [ Designated as safety issue: No ]
Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-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 Uterine Fibroid Impact Questionnaire. [ Time Frame: Months 6, 12, 18 ] [ 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. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in the monthly bleeding score. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
Change from baseline in the 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 ]
Percentage of subjects who discontinue with the intent to have surgery for fibroids. [ Time Frame: During Treatment Period ] [ Designated as safety issue: No ]
Percentage of subjects who responded positively to the Global Efficacy Questions. [ Time Frame: Months 6, 12, 18 ] [ Designated as safety issue: No ]

Enrollment:	166
Study Start Date:	April 2004
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Asoprisnil 10mg Tablet, oral Daily for 18 months
2: Experimental	Drug: Asoprisnil 25 mg Tablet, oral Daily for 18 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 long-term safety of asoprisnil 10 and 25 mg administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
Otherwise good health
Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
Agrees to double-barrier method of contraception
Adequate endometrial biopsy with no significant histological disorder

Exclusion Criteria:

Any abnormal lab or procedure result(s) the study-doctor considers important
History of a blood-clotting disorder
Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away
Significant gynecological disorder, such as endometrial polyp

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156208

Sponsors and Collaborators

Abbott

Investigators


Study Chair:	Medical Director	Abbott

More Information

Responsible Party:	Abbott ( Cynthia Mattia-Goldberg )
Study ID Numbers:	C03-062
First Received:	September 7, 2005
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00156208
Health Authority:	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 October 10, 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00156208