Safety of Treatment of Uterine Fibroids With Asoprisnil

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156208
• Other study ID #: C03-062
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: May 27, 2008
• Start date: April 2004
• Est. completion date: December 2006

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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
10mg Tablet, oral Daily for 18 months
• Asoprisnil
25 mg Tablet, oral Daily for 18 months

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 18 month treatment period	Yes
Secondary	Cumulative and incremental amenorrhea rates.		Each month 1-18	No
Secondary	Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.		Final Visit	No
Secondary	Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.		Final Visit	No
Secondary	Change from baseline in Uterine Fibroid Impact Questionnaire.		Months 6, 12, 18	No
Secondary	Change from baseline in the Work Limitation Questionnaire Index.		Final Visit	No
Secondary	Change from baseline in the two dimensions of the SF-36.		Final Visit	No
Secondary	Change from baseline in the monthly bleeding score.		Final Month	No
Secondary	Change from baseline in the hemoglobin concentration.		Final Visit	No
Secondary	Percent change from baseline in volume of the largest fibroid.		Final Visit	No
Secondary	Percentage of subjects who discontinue with the intent to have surgery for fibroids.		During Treatment Period	No
Secondary	Percentage of subjects who responded positively to the Global Efficacy Questions.		Months 6, 12, 18	No