Study of Asoprisnil in the Treatment of Uterine Fibroids. - Full Text View

Purpose

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

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), Dose Comparison, Parallel Assignment, Safety Study

Official Title:	A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Further study details as provided by Abbott:

Primary Outcome Measures:

Long-term Safety. [ Time Frame: Throughout 2 year treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline in the monthly bleeding score and the number of days with bleeding. [ Time Frame: Each Month ] [ Designated as safety issue: No ]
Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations. [ Time Frame: Months 3, 6, 9,12,15,18, 24 ] [ Designated as safety issue: No ]
Percent change from baseline in volume of the largest fibroid. [ Time Frame: Months 12, 24 ] [ Designated as safety issue: No ]
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms. [ Time Frame: Months 6, 12, 18, 24 ] [ 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: Months 6, 12, 18, 24 ] [ Designated as safety issue: No ]
Change from baseline in the 8 scales of the SF-36 questionnaire. [ Time Frame: Months 6, 12, 18, 24 ] [ Designated as safety issue: No ]
Change from baseline in the 4 scales and overall index of the Work Limitations Questionnaire. [ Time Frame: Months 6, 12, 18, 24 ] [ Designated as safety issue: No ]
Cumulative percent of subjects who achieve amenorrhea. [ Time Frame: Each Month ] [ Designated as safety issue: No ]

Enrollment:	149
Study Start Date:	November 2004
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Asoprisnil Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
2: Experimental	Drug: Asoprisnil Asoprisnil 25 mg Tablet, oral Daily for up to 2 years

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 two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab values and vital signs.

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 who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment
Otherwise in good health
Premenopausal based on Estrogen and FSH levels
Adequate endometrial biopsy with no significant histological disorder
Agrees to use double-barrier method of contraception

Exclusion Criteria:

Any abnormal lab or procedure result(s) the study-doctor considers important
History of a blood-clotting disorder
History of osteoporosis requiring treatment
Any invasive procedure(s) (D&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study
Hemoglobin < 8.0 g/dL
Endometrial thickness ≥ 19 mm

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156156

Sponsors and Collaborators

Abbott

Investigators


Study Chair:	Medical Director	Abbott

More Information

Responsible Party:	Abbott ( Cynthia Mattia-Goldberg )
Study ID Numbers:	A-FB04-078
First Received:	September 7, 2005
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00156156
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

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 10, 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00156156