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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00150644
First received: September 6, 2005
Last updated: May 27, 2008
Last verified: May 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Abbott
Investigators
Study Chair: Medical Director Abbott
  More Information

Publications:
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
Connective Tissue Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on November 23, 2014