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

Purpose

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.

Condition	Intervention	Phase
Uterine Fibroids Leiomyoma	Drug: Asoprisnil Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index. [ Time Frame: Final visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Morphological changes in the endometrium, myometrium and uterine fibroids. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in menstrual pictogram score. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
Percent change from baseline in volume of the largest fibroid. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Endometrial thickness (post-treatment histologic evaluation). [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Change from baseline in endometrial thickness by transvaginal ultrasound. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Percent of ovulatory subjects. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
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. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]

Enrollment:	33
Study Start Date:	July 2003
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Asoprisnil Asoprisnil 10mg Tablet, oral Daily for 12 weeks Other Name: J867
Experimental: 2	Drug: Asoprisnil Asoprisnil 25 mg Tablet, oral Daily for 12 weeks Other Name: J867
Placebo Comparator: 3	Drug: Placebo Placebo Tablet, oral Daily for 12 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150644

Sponsors and Collaborators

Abbott

Investigators

Study Chair:

Medical Director

Abbott

More Information

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. Epub 2007 Mar 5.

Responsible Party:	Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier:	NCT00150644 History of Changes
Other Study ID Numbers:	C02-003
Study First Received:	September 6, 2005
Last Updated:	May 27, 2008
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Keywords provided by Abbott:

Fibroid Uterus
Leiomyoma
Uterine Fibroids
Hysterectomy
Asoprisnil

Additional relevant MeSH terms:

Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 19, 2013