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A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00156182
First Posted: September 12, 2005
Last Update Posted: March 4, 2009
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.
Information provided by:
Abbott
  Purpose
This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

Condition Intervention Phase
Leiomyoma Drug: Asoprisnil Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144 [ Time Frame: Treatment months 3 and 6 and Post-treatment months 3 and 6 ]
  • Percentage of subjects that achieved amenorrhea. [ Time Frame: Treatment months 1-6 ]

Secondary Outcome Measures:
  • Improvement in hematologic parameters. [ Time Frame: Treatment months 2,4,and 6 ]
  • Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale [ Time Frame: Treatment Months 1-6 ]
  • Change from baseline in uterine size in gestational weeks. [ Time Frame: Months 3 and 6 ]
  • Duration of amenorrhea. [ Time Frame: Start of previous study to first post-treatment menses. ]
  • Response to global efficacy question regarding improvement of fibroid symptoms. [ Time Frame: Month 6 ]
  • Mean change from baseline for endocrine determinations. [ Time Frame: Months 2,4 and 6 ]

Enrollment: 38
Study Start Date: April 2001
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Asoprisnil
10mg Tablet, oral Daily for 6 months

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 long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed dosing and Day 84 procedures at sites in study M99-144
  • No interruption of dosing
  • Otherwise continued good health

Exclusion Criteria:

  • Any abnormal lab result the study-doctor considers significant
  • History of severe reaction to or current use of hormone therapy
  • History of alcohol or drug abuse
  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): NCT00156182


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

Responsible Party: Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier: NCT00156182     History of Changes
Other Study ID Numbers: M01-275
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: March 4, 2009
Last Verified: May 2008

Keywords provided by Abbott:
Fibroid Uterus
Leiomyoma
Uterine Fibroids
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