Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

Menorrhagia Clinical Trial

Official title:

A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156195
• Other study ID #: M01-391
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: May 27, 2008
• Start date: September 2003
• Est. completion date: January 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 asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory 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: 523
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively

• Otherwise in good health

• Premenopausal based on Estrogen and FSH levels

• Agrees to use of 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

• Significant gynecological disorder such as confirmed endometrial polyp

• Hemoglobin < 8.0 g/dL

• 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.

Study Design

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

Related Conditions & MeSH terms

• Leiomyoma
• Menorrhagia
• Metrorrhagia

Intervention

Drug:
• Asoprisnil
10 mg Tablet, oral Daily for 12 months
• Asoprisnil
25 mg Tablet, oral Daily for 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.		Month 12	No
Secondary	The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.		Month 6	No
Secondary	Change from baseline in menstrual pictogram bleeding score.		Final Month	No
Secondary	Change from baseline in the number of days with bleeding.		Final Month	No
Secondary	Change from baseline in hemoglobin concentration.		Final Visit	No
Secondary	Percent change from baseline in the volume of the largest fibroid.		Final Visit	No
Secondary	Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.		Final Visit	No
Secondary	Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.		Final Visit	No
Secondary	Cumulative percent of subjects who achieve amenorrhea.		Each Month	No