A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy

A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.

The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.

Study Overview

• Status: Completed
• Conditions: Leiomyoma; Uterine Fibroids
• Intervention / Treatment: Drug: Asoprisnil; Drug: Asoprisnil; Drug: Placebo

Detailed Description

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Premenopausal women, at least 18 years of age
• Diagnosis of uterine fibroid(s), confirmed by ultrasound
• History of menstrual cycles between 17 and 42 days
• Otherwise in good health
• Scheduled for a hysterectomy at the end of the treatment period
• Negative pregnancy test
• Agrees to double barrier method of contraception
• Pap test with no evidence of malignancy or pre-malignant changes
• Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

• Less than 3 months after having a baby or breast-feeding
• Any abnormal lab or procedure result the study-doctor considers important
• Severe reaction(s) to or are currently using any hormone therapy
• History of cancer or alcohol or drug abuse
• Diagnosis of Polycystic Ovary Syndrome
• History of prolactinoma
• Current use of Intrauterine Device
• Significant gynecological disorder
• Uterine size > 32 weeks gestation
• Current diagnosis of endometriosis
• Uterine artery embolization within 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Asoprisnil; Asoprisnil 10mg Tablet, oral Daily for 12 weeks; Other Names: J867; Drug: Asoprisnil; Asoprisnil 25 mg Tablet, oral Daily for 12 weeks; Other Names: J867
Experimental: 2	Drug: Asoprisnil; Asoprisnil 10mg Tablet, oral Daily for 12 weeks; Other Names: J867; Drug: Asoprisnil; Asoprisnil 25 mg Tablet, oral Daily for 12 weeks; Other Names: J867
Placebo Comparator: 3	Drug: Placebo; Placebo Tablet, oral Daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.	Final visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent change from baseline in volume of the largest fibroid.	Final Visit
Change from baseline in menstrual pictogram score.	Final Month
Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index.	Final Visit
Morphological changes in the endometrium, myometrium and uterine fibroids.	Final Visit
Endometrial thickness (post-treatment histologic evaluation).	Final Visit
Change from baseline in endometrial thickness by transvaginal ultrasound.	Final Visit
Percent of ovulatory subjects.	Final Month
Change from baseline in the Uterine Fibroid Symptom-Quality of Life total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.	Final Visit

Collaborators and Investigators

• Sponsor: Abbott

Publications and helpful links

General Publications

• Williams AR, Critchley HO, Osei J, Ingamells S, Cameron IT, Han C, Chwalisz K. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod. 2007 Jun;22(6):1696-704. doi: 10.1093/humrep/dem026. Epub 2007 Mar 5.

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: September 6, 2005
• First Submitted That Met QC Criteria: September 6, 2005
• First Posted (Estimate): September 8, 2005

Study Record Updates

• Last Update Posted (Estimate): May 29, 2008
• Last Update Submitted That Met QC Criteria: May 27, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Uterine Fibroids; Hysterectomy; Leiomyoma; Fibroid Uterus; Asoprisnil
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: C02-003