A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

Uterine Fibroids Clinical Trial

Official title:

A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152256
• Other study ID #: C02-037
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: May 27, 2008
• Start date: September 2003
• Est. completion date: February 2005

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 safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.

Description:

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 53 Years

Eligibility

Inclusion Criteria:

• Premenopausal women

• History of regular menstrual cycles (21-42 days)

• Diagnosis of uterine fibroid(s)

• Abnormal vaginal bleeding associated with uterine fibroids

• Otherwise in good health

• Subject must have at least one fibroid with a diameter = 2 cm or multiple small fibroids with a uterine volume of = 200 cm3

Exclusion Criteria:

• Less than 3 months postpartum and post-lactation

• Previous myomectomy within 1 year

• Any abnormal lab or procedure result the study-doctor considers important

• Severe reaction(s) to or are currently using any hormone therapy

• History of osteoporosis or other bone disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Asoprisnil
Asoprisnil 10 mg Tablet, oral Daily for 6 months
• Asoprisnil
Asoprisnil 25mg Tablet, oral Daily for 6 months
• Placebo
Placebo Tablet, oral Daily for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative percent of subjects achieving amenorrhea.		Month 3	No
Secondary	Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-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 the Work Limitation Questionnaire Index.		Final Visit	No
Secondary	Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).		Final Visit	No
Secondary	Change from baseline in the monthly bleeding score.		Final Visit	No
Secondary	Change from baseline in the hemoglobin concentration.		Final Visit	No
Secondary	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.		During treatment period	No
Secondary	Percentage of subjects who respond positively to the global efficacy question.		Final Visit	No