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

Uterine Fibroids Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150644
• Other study ID #: C02-003
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: May 27, 2008
• Start date: July 2003
• Est. completion date: May 2005

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

References & Publications (1)

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 leiom — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.		Final visit	No
Secondary	Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index.		Final Visit	No
Secondary	Morphological changes in the endometrium, myometrium and uterine fibroids.		Final Visit	No
Secondary	Change from baseline in menstrual pictogram score.		Final Month	No
Secondary	Percent change from baseline in volume of the largest fibroid.		Final Visit	No
Secondary	Endometrial thickness (post-treatment histologic evaluation).		Final Visit	No
Secondary	Change from baseline in endometrial thickness by transvaginal ultrasound.		Final Visit	No
Secondary	Percent of ovulatory subjects.		Final Month	No
Secondary	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	No