Study of Asoprisnil in the Treatment of Uterine Fibroids.

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156156
• Other study ID #: A-FB04-078
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: May 27, 2008
• Start date: November 2004
• Est. completion date: February 2007

Study information

• Verified date: May 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibroid Uterus
• Leiomyoma
• Menorrhagia
• Metrorrhagia
• Uterine Fibroids

Intervention

Drug:
• Asoprisnil
Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
• Asoprisnil
Asoprisnil 25 mg Tablet, oral Daily for up to 2 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term Safety.		Throughout 2 year treatment period	Yes
Secondary	Change from baseline in the monthly bleeding score and the number of days with bleeding.		Each Month	No
Secondary	Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.		Months 3, 6, 9,12,15,18, 24	No
Secondary	Percent change from baseline in volume of the largest fibroid.		Months 12, 24	No
Secondary	Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.		Months 6, 12, 18, 24	No
Secondary	Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.		Months 6, 12, 18, 24	No
Secondary	Change from baseline in the 8 scales of the SF-36 questionnaire.		Months 6, 12, 18, 24	No
Secondary	Change from baseline in the 4 scales and overall index of the Work Limitations Questionnaire.		Months 6, 12, 18, 24	No
Secondary	Cumulative percent of subjects who achieve amenorrhea.		Each Month	No