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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00150644
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : May 29, 2008
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Leiomyoma Drug: Asoprisnil Drug: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : July 2003
Primary Completion Date : May 2005
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index. [ Time Frame: Final visit ]

Secondary Outcome Measures :
  1. Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index. [ Time Frame: Final Visit ]
  2. Morphological changes in the endometrium, myometrium and uterine fibroids. [ Time Frame: Final Visit ]
  3. Change from baseline in menstrual pictogram score. [ Time Frame: Final Month ]
  4. Percent change from baseline in volume of the largest fibroid. [ Time Frame: Final Visit ]
  5. Endometrial thickness (post-treatment histologic evaluation). [ Time Frame: Final Visit ]
  6. Change from baseline in endometrial thickness by transvaginal ultrasound. [ Time Frame: Final Visit ]
  7. Percent of ovulatory subjects. [ Time Frame: Final Month ]
  8. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150644

Sponsors and Collaborators
Study Chair: Medical Director Abbott
More Information

Responsible Party: Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier: NCT00150644     History of Changes
Other Study ID Numbers: C02-003
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008

Keywords provided by Abbott:
Fibroid Uterus
Uterine Fibroids

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases