A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

Leiomyoma Clinical Trial

Official title:

A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156182
• Other study ID #: M01-275
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: March 3, 2009
• Start date: April 2001
• Est. completion date: December 2001

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

This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

Description:

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Completed dosing and Day 84 procedures at sites in study M99-144

• No interruption of dosing

• Otherwise continued good health

Exclusion Criteria:

• Any abnormal lab result the study-doctor considers significant

• History of severe reaction to or current use of hormone therapy

• History of alcohol or drug abuse

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Drug:
• Asoprisnil
10mg 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	Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144		Treatment months 3 and 6 and Post-treatment months 3 and 6	No
Primary	Percentage of subjects that achieved amenorrhea.		Treatment months 1-6	No
Secondary	Improvement in hematologic parameters.		Treatment months 2,4,and 6	Yes
Secondary	Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale		Treatment Months 1-6	No
Secondary	Change from baseline in uterine size in gestational weeks.		Months 3 and 6	No
Secondary	Duration of amenorrhea.		Start of previous study to first post-treatment menses.	No
Secondary	Response to global efficacy question regarding improvement of fibroid symptoms.		Month 6	No
Secondary	Mean change from baseline for endocrine determinations.		Months 2,4 and 6	Yes