A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

Leiomyoma Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160459
• Other study ID #: M99-144
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: May 27, 2008
• Start date: May 2000
• Est. completion date: July 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 safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.

Description:

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: July 2001
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Women between 18 and 49 years of age

• Diagnosis of either 1 or more uterine fibroids

• History of regular menstrual cycles of 21 to 35 days in length.

Exclusion Criteria:

• Any abnormal lab result the study-doctor considers significant

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

• History of osteoporosis or other bone disease

• History of uterine artery embolization, cryomyolysis, or electrical myolysis

• Subject currently breast feeding

• Hemoglobin < 8 g/dL at baseline

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

• Leiomyoma

Intervention

Drug:
• Asoprisnil
5 mg Tablet, oral Daily for 12 weeks
• Asoprisnil
10 mg Tablet, oral Daily for 12 weeks
• Asoprisnil
25 mg Tablet, oral Daily for 12 weeks
• Placebo
Tablet, oral Daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

References & Publications (1)

Chwalisz K, Larsen L, Mattia-Goldberg C, Edmonds A, Elger W, Winkel CA. A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata. Fertil Steril. 2007 Jun;87(6):1399-412. Epub 2007 F — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in uterine volume and volume of the largest fibroid.		Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.	No
Primary	Duration of amenorrhea		Day 1 to 1st post treatment menses	No
Secondary	Change from baseline in uterine size in gestational weeks.		Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6	No
Secondary	Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.		Week 12 and final visit	No
Secondary	Percentage of days with bleeding.		Day 1 through end of 1st post-treatment menses	No
Secondary	Changes in hematologic and iron parameters.		Baseline to each visit	Yes
Secondary	Uterine fibroid symptom improvement.		Baseline to each visit	No
Secondary	Response to Global Efficacy Question regarding improvement in fibroid symptoms.		Week 12 and Final Visit	No