Study of Asoprisnil in the Treatment of Uterine Fibroids.

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00156156

Collaborator

(none)

149

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids	Drug: Asoprisnil Drug: Asoprisnil	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Asoprisnil Asoprisnil 10 mg Tablet, oral Daily for up to 2 years Other Names: J867
Experimental: 2	Drug: Asoprisnil Asoprisnil 25 mg Tablet, oral Daily for up to 2 years Other Names: J867

Arm

Intervention/Treatment

Experimental: 1

Drug: Asoprisnil

Asoprisnil 10 mg Tablet, oral Daily for up to 2 years

Other Names:

J867

Experimental: 2

Drug: Asoprisnil

Asoprisnil 25 mg Tablet, oral Daily for up to 2 years

Other Names:

J867

Outcome Measures

Primary Outcome Measures

Long-term Safety. [Throughout 2 year treatment period]

Secondary Outcome Measures

Change from baseline in the monthly bleeding score and the number of days with bleeding. [Each Month]
Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations. [Months 3, 6, 9,12,15,18, 24]
Percent change from baseline in volume of the largest fibroid. [Months 12, 24]
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms. [Months 6, 12, 18, 24]
Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score. [Months 6, 12, 18, 24]
Change from baseline in the 8 scales of the SF-36 questionnaire. [Months 6, 12, 18, 24]
Change from baseline in the 4 scales and overall index of the Work Limitations Questionnaire. [Months 6, 12, 18, 24]
Cumulative percent of subjects who achieve amenorrhea. [Each Month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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