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Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00156195
First received: September 7, 2005
Last updated: May 27, 2008
Last verified: May 2008
History of Changes

September 7, 2005
May 27, 2008
September 2003
January 2007   (final data collection date for primary outcome measure)
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention during the treatment period or who discontinue treatment because of planned surgical/invasive intervention
Complete list of historical versions of study NCT00156195 on ClinicalTrials.gov Archive Site
  • The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Change from baseline in menstrual pictogram bleeding score. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
  • Change from baseline in the number of days with bleeding. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
  • Change from baseline in hemoglobin concentration. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Percent change from baseline in the volume of the largest fibroid. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Cumulative percent of subjects who achieve amenorrhea. [ Time Frame: Each Month ] [ Designated as safety issue: No ]
Secondary outcomes in this study will assess improvement in bleeding symptoms associated with uterine fibroids in symptomatic women and their quality-of-life.
Not Provided
Not Provided
 
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Leiomyoma
  • Menorrhagia
  • Metrorrhagia
  • Drug: Asoprisnil
    10 mg Tablet, oral Daily for 12 months
  • Drug: Asoprisnil
    25 mg Tablet, oral Daily for 12 months
  • Experimental: 1
    Intervention: Drug: Asoprisnil
  • Experimental: 2
    Intervention: Drug: Asoprisnil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
523
January 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
  • Otherwise in good health
  • Premenopausal based on Estrogen and FSH levels
  • Agrees to use of double barrier method of contraception
  • Adequate endometrial biopsy with no significant histological disorder

Exclusion Criteria:

  • Any abnormal lab or procedure result(s) the study-doctor considers important
  • Significant gynecological disorder such as confirmed endometrial polyp
  • Hemoglobin < 8.0 g/dL
  • History of a blood-clotting disorder
  • Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00156195
M01-391
Yes
Cynthia Mattia-Goldberg, Abbott
Abbott
Not Provided
Study Chair: Medical Director Abbott
Abbott
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP